CVI Drug Coated Balloon First In Human Trial

Spectranetics

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Device: Percutaneous Transluminal Angioplasty

Study type

Interventional

Funder types

Industry

Identifiers

NCT02110524

TP1027

Details and patient eligibility

About

The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or popliteal arteries.

The primary endpoint for this analysis is late lumen loss at six (6) months.

Full description

Prospective, controlled, multi-center, open, single arm study

Main cohort: 50; pre-specified treatment group: 30. Total patients: 80

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery
De novo or restenotic lesion(s) >70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation).
Target vessel reference diameter ≥3 mm and ≤7 mm (by visual estimation).
Rutherford classification of 2, 3 or 4

Exclusion criteria

Lesion length is <3 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.
Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.
Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.