Brief Summary
The purpose of this study is to test if dexamethasone, an anti-inflammatory medication approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue around the blood vessel wall at the time of an angioplasty or atherectomy.
Brief Title
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
Detailed Description
This is an investigator-initiated, single-arm, external pilot study to assess the safety and feasibility of perivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy.
Although dexamethasone is approved by the FDA for injection into blood, skin or joints, it has not been approved by the FDA for injection around blood vessels. The investigators want to find out if this procedure helps prevent re-narrowing of the blood vessel after angioplasty or atherectomy. The dexamethasone will be injected with a Bullfrog® Micro-Infusion catheter, which is an FDA-approved device for injecting medications into tissues around the blood vessel wall. The Bullfrog® Micro-Infusion catheter is similar to other balloon tipped catheters except that it contains a microneedle covered by a fold of semi-rigid balloon. Once the balloon is inflated, the microneedle is uncovered and a medication can be injected into the tissue around the blood vessel.
Although dexamethasone is approved by the FDA for injection into blood, skin or joints, it has not been approved by the FDA for injection around blood vessels. The investigators want to find out if this procedure helps prevent re-narrowing of the blood vessel after angioplasty or atherectomy. The dexamethasone will be injected with a Bullfrog® Micro-Infusion catheter, which is an FDA-approved device for injecting medications into tissues around the blood vessel wall. The Bullfrog® Micro-Infusion catheter is similar to other balloon tipped catheters except that it contains a microneedle covered by a fold of semi-rigid balloon. Once the balloon is inflated, the microneedle is uncovered and a medication can be injected into the tissue around the blood vessel.
Completion Date
Completion Date Type
Actual
Conditions
Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
* Patient is \> 40 years and \< 80 years of age
* Patient has severe, lifestyle-limiting claudication or critical limb ischemia (Rutherford classification 3-6)
* Patient has TASC II A, B or C disease, SFA revascularization is preferred over medical management, and endovascular approach is preferred revascularization strategy
* Patient has a resting ABI of \<0.9 or an abnormal treadmill ABI. Patients with incompressible arteries must have a TBI \<0.8
* Patient has at least 1 infra-popliteal run-off vessel with patency to the ankle without a \>50% stenosis
* Successful crossing of the lesion with guidewire and successful atherectomy or angioplasty with residual stenosis \<30% as compared to the reference vessels
* Atherectomy procedure does not result in embolization, arteriovenous fistula or perforation
* Patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12 and 24 months (routine clinical care)
Exclusion Criteria:
* Patient is simultaneously participating in another investigational drug or device study
* Patient is pregnant or breast-feeding
* Patient has cancer, autoimmune disease, bone marrow or organ transplant, or other concurrent medical illness requiring immunosuppressive therapy
* Patient has end-stage renal disease and chronic kidney disease (eGFR\<30)
* Patient has an active infection
* Patient has a known hypersensitivity or contraindication to heparin, contrast agents, excipients of Dexamethasone Sodium Phosphate Injection, USP, dexamethasone, or other glucocorticoids
* Patient has a life expectancy of less than one year
* Patient is \> 40 years and \< 80 years of age
* Patient has severe, lifestyle-limiting claudication or critical limb ischemia (Rutherford classification 3-6)
* Patient has TASC II A, B or C disease, SFA revascularization is preferred over medical management, and endovascular approach is preferred revascularization strategy
* Patient has a resting ABI of \<0.9 or an abnormal treadmill ABI. Patients with incompressible arteries must have a TBI \<0.8
* Patient has at least 1 infra-popliteal run-off vessel with patency to the ankle without a \>50% stenosis
* Successful crossing of the lesion with guidewire and successful atherectomy or angioplasty with residual stenosis \<30% as compared to the reference vessels
* Atherectomy procedure does not result in embolization, arteriovenous fistula or perforation
* Patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12 and 24 months (routine clinical care)
Exclusion Criteria:
* Patient is simultaneously participating in another investigational drug or device study
* Patient is pregnant or breast-feeding
* Patient has cancer, autoimmune disease, bone marrow or organ transplant, or other concurrent medical illness requiring immunosuppressive therapy
* Patient has end-stage renal disease and chronic kidney disease (eGFR\<30)
* Patient has an active infection
* Patient has a known hypersensitivity or contraindication to heparin, contrast agents, excipients of Dexamethasone Sodium Phosphate Injection, USP, dexamethasone, or other glucocorticoids
* Patient has a life expectancy of less than one year
Inclusion Criteria
Inclusion Criteria:
* Patient is \> 40 years and \< 80 years of age
* Patient has severe, lifestyle-limiting claudication or critical limb ischemia (Rutherford classification 3-6)
* Patient has TASC II A, B or C disease, SFA revascularization is preferred over medical management, and endovascular approach is preferred revascularization strategy
* Patient has a resting ABI of \<0.9 or an abnormal treadmill ABI. Patients with incompressible arteries must have a TBI \<0.8
* Patient has at least 1 infra-popliteal run-off vessel with patency to the ankle without a \>50% stenosis
* Successful crossing of the lesion with guidewire and successful atherectomy or angioplasty with residual stenosis \<30% as compared to the reference vessels
* Atherectomy procedure does not result in embolization, arteriovenous fistula or perforation
* Patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12 and 24 months (routine clinical care)
* Patient is \> 40 years and \< 80 years of age
* Patient has severe, lifestyle-limiting claudication or critical limb ischemia (Rutherford classification 3-6)
* Patient has TASC II A, B or C disease, SFA revascularization is preferred over medical management, and endovascular approach is preferred revascularization strategy
* Patient has a resting ABI of \<0.9 or an abnormal treadmill ABI. Patients with incompressible arteries must have a TBI \<0.8
* Patient has at least 1 infra-popliteal run-off vessel with patency to the ankle without a \>50% stenosis
* Successful crossing of the lesion with guidewire and successful atherectomy or angioplasty with residual stenosis \<30% as compared to the reference vessels
* Atherectomy procedure does not result in embolization, arteriovenous fistula or perforation
* Patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12 and 24 months (routine clinical care)
Gender
All
Gender Based
false
Keywords
Peripheral Arterial Disease
Femoral popliteal lesions
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
40 Years
NCT Id
NCT01507558
Org Class
Other
Org Full Name
University of California, San Francisco
Org Study Id
10-02101
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
Primary Outcomes
Outcome Description
Freedom from death, vessel dissection, thrombosis or extravasation at 30 days post-procedure.
Outcome Measure
Safety Outcome Measures:
Outcome Time Frame
30 days
Outcome Description
Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.
Outcome Measure
Effectiveness Outcome Measures:
Outcome Time Frame
6 months
Secondary Outcomes
Outcome Description
Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel
Outcome Time Frame
24 months
Outcome Measure
Safety Outcome Measures:
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Slovut
Investigator Email
DSlovut@montefiore.org
Investigator Phone