Brief Summary
The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.
Brief Title
Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon
Detailed Description
The registry is a prospective, multi-center, single-arm, real-world study to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries). Follow-up for all treated subjects will be performed at hospital discharge, 30 days, and 6 and 12 months post-index procedure.
Completion Date
Completion Date Type
Actual
Conditions
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Eligibility Criteria
Inclusion Criteria:
1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
2. Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
3. Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
4. Subject must have a target lesion (de novo lesion or prior failed treatment) that can be treated with the UltraScore™ Focused Force PTA balloon according to the Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be treated for this study.
5. Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
6. The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).
Exclusion Criteria:
1. Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed).
2. The subject has a single target lesion that involves both ATK and BTK arteries.
3. The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis).
4. The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon.
5. The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon.
6. The subject has acute limb ischemia.
7. The subject has been assessed Rutherford category 6.
8. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
9. The subject has another medical condition or is currently participating in an investigational drug or another device study that, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
2. Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
3. Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
4. Subject must have a target lesion (de novo lesion or prior failed treatment) that can be treated with the UltraScore™ Focused Force PTA balloon according to the Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be treated for this study.
5. Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
6. The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).
Exclusion Criteria:
1. Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed).
2. The subject has a single target lesion that involves both ATK and BTK arteries.
3. The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis).
4. The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon.
5. The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon.
6. The subject has acute limb ischemia.
7. The subject has been assessed Rutherford category 6.
8. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
9. The subject has another medical condition or is currently participating in an investigational drug or another device study that, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
Inclusion Criteria
Inclusion Criteria:
1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
2. Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
3. Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
4. Subject must have a target lesion (de novo lesion or prior failed treatment) that can be treated with the UltraScore™ Focused Force PTA balloon according to the Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be treated for this study.
5. Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
6. The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).
1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
2. Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
3. Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
4. Subject must have a target lesion (de novo lesion or prior failed treatment) that can be treated with the UltraScore™ Focused Force PTA balloon according to the Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be treated for this study.
5. Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
6. The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
21 Years
NCT Id
NCT03193619
Org Class
Industry
Org Full Name
C. R. Bard
Org Study Id
BPV-16-001
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon
Primary Outcomes
Outcome Description
Optimal result is defined as ≤30% residual stenosis without major flow-limiting dissection, as measured by angiographic imaging. Major flow limiting dissections are classified by the National Heart, Lung, and Blood Institute (NHLBI) as Grade D (Spiral luminal filling defects), Grade E (Appearance of new and persistent filling defects with reduced flow), and Grade F (Total occlusion without distal flow).
Outcome Measure
Number of Participants That Achieve Optimal PTA Results
Outcome Time Frame
Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Outcome Description
Technical success is determined subjectively by the investigator according to delivery location of the study device relative to the target lesion, as assessed by angiographic imaging, and inflation without movement.
Outcome Measure
Number of Participants With Technical Success of Use of UltraScore™ Focused Force PTA Balloon
Outcome Time Frame
Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Secondary Outcomes
Outcome Description
Number of participants who needed stent placement for abrupt or threatened artery closure caused by arterial dissection immediately following index procedure.
Outcome Time Frame
Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Outcome Measure
Number of Participants With Bail-out Stenting Due to Dissection
Outcome Description
TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure
Outcome Time Frame
30 days post-index procedure
Outcome Measure
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
Outcome Description
TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure
Outcome Time Frame
6 months post-index procedure
Outcome Measure
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
Outcome Description
TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure
Outcome Time Frame
12 months post-index procedure
Outcome Measure
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
Outcome Description
Major amputation is defined as above the ankle amputation
Outcome Time Frame
30 days post-index procedure
Outcome Measure
Number of Participants That Did Not Have a Major Amputation of the Target Limb
Outcome Description
Major amputation is defined as above the ankle amputation
Outcome Time Frame
6 months post-index procedure
Outcome Measure
Number of Participants That Did Not Have a Major Amputation of the Target Limb
Outcome Description
Major amputation is defined as above the ankle amputation
Outcome Time Frame
12 months post-index procedure
Outcome Measure
Number of Participants That Did Not Have a Major Amputation of the Target Limb
Outcome Description
Resting ankle brachial index (ABI) for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline. ABI measurements: Mild to moderate if the ABI is between 0.4 and 0.9, and an ABI less than 0.40 is suggestive of severe PAD \[19\]. An ABI value greater than 1.3 is also considered abnormal, suggestive of non-compressible vessels.
Outcome Time Frame
30 days post-index procedure
Outcome Measure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
Outcome Description
Resting ankle brachial index (ABI) for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline. ABI measurements: Mild to moderate if the ABI is between 0.4 and 0.9, and an ABI less than 0.40 is suggestive of severe PAD \[19\]. An ABI value greater than 1.3 is also considered abnormal, suggestive of non-compressible vessels.
Outcome Time Frame
6 months post-index procedure
Outcome Measure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
Outcome Description
Resting ankle brachial index (ABI) for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline. ABI measurements: Mild to moderate if the ABI is between 0.4 and 0.9, and an ABI less than 0.40 is suggestive of severe PAD \[19\]. An ABI value greater than 1.3 is also considered abnormal, suggestive of non-compressible vessels.
Outcome Time Frame
12 months post-index procedure
Outcome Measure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
Outcome Description
Rutherford classification (RC):
0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain
1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after \>2 blocks (\>600 feet, or 2 football fields)
2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields)
3. Severe claudication: ischemic limb muscle pain that limits walking to \<1 block (\<300 feet, or 1 football field)
4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion
5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia
6. Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts
0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain
1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after \>2 blocks (\>600 feet, or 2 football fields)
2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields)
3. Severe claudication: ischemic limb muscle pain that limits walking to \<1 block (\<300 feet, or 1 football field)
4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion
5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia
6. Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts
Outcome Time Frame
30 days post-index procedure
Outcome Measure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
Outcome Description
Rutherford classification (RC):
0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain
1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after \>2 blocks (\>600 feet, or 2 football fields)
2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields)
3. Severe claudication: ischemic limb muscle pain that limits walking to \<1 block (\<300 feet, or 1 football field)
4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion
5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia
6. Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts
0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain
1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after \>2 blocks (\>600 feet, or 2 football fields)
2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields)
3. Severe claudication: ischemic limb muscle pain that limits walking to \<1 block (\<300 feet, or 1 football field)
4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion
5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia
6. Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts
Outcome Time Frame
6 months post-index procedure
Outcome Measure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
Outcome Description
Rutherford classification (RC):
0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain
1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after \>2 blocks (\>600 feet, or 2 football fields)
2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields)
3. Severe claudication: ischemic limb muscle pain that limits walking to \<1 block (\<300 feet, or 1 football field)
4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion
5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia
6. Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts
0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain
1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after \>2 blocks (\>600 feet, or 2 football fields)
2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields)
3. Severe claudication: ischemic limb muscle pain that limits walking to \<1 block (\<300 feet, or 1 football field)
4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion
5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia
6. Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts
Outcome Time Frame
12 months post-index procedure
Outcome Measure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
Outcome Description
ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency (patent or open target vessel) is measured by duplex ultrasound (DUS) core lab; the core lab determines whether target vessel is patent/open.
Outcome Time Frame
30 days post-index procedure
Outcome Measure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
Outcome Description
ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency (patent or open target vessel) is measured by duplex ultrasound (DUS) core lab; the core lab determines whether target vessel is patent/open.
Outcome Time Frame
6 months post-index procedure
Outcome Measure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
Outcome Description
ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency (patent or open target vessel) is measured by duplex ultrasound (DUS) core lab; the core lab determines whether target vessel is patent/open.
Outcome Time Frame
12 months post-index procedure
Outcome Measure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
This study will include a maximum of 350 subjects at up to 45 U.S. sites. All subjects will have peripheral arterial disease (PAD; a stenotic lesion of the SFA, popliteal, or infra-popliteal arteries).
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jose Wiley
Investigator Email
jwileyra@montefiore.org
Investigator Phone