Brief Summary
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
Brief Title
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
Completion Date
Completion Date Type
Estimated
Conditions
Critical Limb Ischemia
Eligibility Criteria
Inclusion Criteria:
* Rutherford Clinical Category 4-5
* Life expectancy \> 1 year
* Significant stenosis ≥70%
* Patent inflow artery
* Target vessel(s) diameter between 2 and 4 mm
* Target vessel(s) reconstitute(s) at the ankle
Exclusion Criteria:
* Pregnant or planning to become pregnant
* History of stroke within 3 months
* Planned major amputation
* eGFR \<30
* Acute limb ischemia
* Prior stent placement in target lesion
* Rutherford Clinical Category 4-5
* Life expectancy \> 1 year
* Significant stenosis ≥70%
* Patent inflow artery
* Target vessel(s) diameter between 2 and 4 mm
* Target vessel(s) reconstitute(s) at the ankle
Exclusion Criteria:
* Pregnant or planning to become pregnant
* History of stroke within 3 months
* Planned major amputation
* eGFR \<30
* Acute limb ischemia
* Prior stent placement in target lesion
Inclusion Criteria
Inclusion Criteria:
* Rutherford Clinical Category 4-5
* Life expectancy \> 1 year
* Significant stenosis ≥70%
* Patent inflow artery
* Target vessel(s) diameter between 2 and 4 mm
* Target vessel(s) reconstitute(s) at the ankle
* Rutherford Clinical Category 4-5
* Life expectancy \> 1 year
* Significant stenosis ≥70%
* Patent inflow artery
* Target vessel(s) diameter between 2 and 4 mm
* Target vessel(s) reconstitute(s) at the ankle
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
18 Years
NCT Id
NCT03175744
Org Class
Industry
Org Full Name
Spectranetics Corporation
Org Study Id
D032150
Overall Status
Suspended
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries
Primary Outcomes
Outcome Description
Composite of major amputation or major reintervention on a per patient basis
Outcome Measure
Freedom from Major Adverse Limb Event (MALE)
Outcome Time Frame
30 days
Outcome Description
Death on a per patient basis
Outcome Measure
Freedom from Perioperative Death (POD)
Outcome Time Frame
30 days
Outcome Description
Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Outcome Measure
Patency
Outcome Time Frame
6 months
Outcome Description
Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Outcome Measure
Limb Salvage
Outcome Time Frame
6 months
Secondary Outcomes
Outcome Description
Rate of clinically-driven target lesion revascularization
Outcome Time Frame
6 months
Outcome Measure
Clinically-driven target lesion revascularization
Outcome Description
Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention
Outcome Time Frame
6 months
Outcome Measure
Major adverse event rates
Outcome Description
Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention
Outcome Time Frame
6 months
Outcome Measure
Patency rate
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jose Wiley
Investigator Email
jwileyra@montefiore.org
Investigator Phone