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About
Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries.
Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions.
Full description
Cohort 1:
The purpose of this single arm study is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries.
Cohort 2:
A second cohort is being added to evaluate this patient population for treatment of in-stent restenotic lesions.
Cohort 1:
Prospective, multi-center, single-arm study.
Cohort 2:
Prospective, multi-center, single-arm study compared to a historical control.
Cohort 1:
Follow-up assessments will occur at discharge, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months following the study procedure.
Cohort 2:
Follow-up assessments will occur at discharge, 1 month, 6 months, 12 months, 24 months and 36 months following the study procedure.
Enrollment
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Inclusion and exclusion criteria
Cohort 1: General Inclusion Criteria:
Cohort 1: Angiographic Inclusion Criteria:
Cohort 1: General Exclusion Criteria:
Cohort 1: Angiographic Exclusion Criteria:
Cohort 2: General Inclusion Criteria:
Cohort 2: Angiographic Inclusion Criteria:
Cohort 2: General Exclusion Criteria:
Cohort 2: Angiographic Exclusion Criteria:
Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis
≥50% diameter stenosis (DS) that is not successfully treated prior to index procedure (e.g. where a perforation occurred requiring a covered stent) or with final residual stenosis ≥ 30% documented by angiography.
Identification of any lesion of the native vessel (excludes ISR) above the target stent in the femoropopliteal segment >50% that is not successfully treated prior to index procedure (e.g. complication requiring additional treatment) or with final residual stenosis >30% documented by angiography. Drug eluting stent (DES) and drug coated balloon (DCB) will not be allowed. The lesion length must be treatable with a single stent (if required). The lesion must not be contiguous with the target lesion; at least 2 cm of normal appearing vessel between the lesion and target lesion/ target stent or between deployed stent (if required) and the target lesion/ target stent.
Has an acute or sub-acute intraluminal thrombus within the target vessel.
Has an aneurysm (at least twice the reference vessel diameter) located in the target vessel, abdominal aorta, iliac, or popliteal arteries.
Has perforation, dissection or other injury of the access or target vessel requiring stenting or surgical intervention prior to enrollment.
Has no normal arterial segment proximal to the target lesion in which duplex ultrasound velocity ratios can be measured.
Requires use of adjunctive therapies (i.e., laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy).
Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.
Primary purpose
Allocation
Interventional model
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499 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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