CVI Drug Coated Balloon First In Human Trial

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Percutaneous Transluminal Angioplasty

• Registration Number: NCT02110524
• Lead Sponsor: Spectranetics Corporation

Brief Summary

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.

Detailed Description

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

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

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2012-09
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-25
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CVI Drug Coated Balloon	Percutaneous Transluminal Angioplasty	-

Primary Outcome Measures

Name	Time	Method
Primary endpoint: Angiographic late lumen loss	6Month	difference between minimum lumen diameter after intervention and follow up.

Secondary Outcome Measures

Name	Time	Method
Secondary safety endpoint: Major Adverse Event (MAE) rate	6Months	composite rate of cardiovascular death, index limb amputation and ischemia driven target lesion revascularization (TLR).

Trial Locations

Locations (1)

Jewish Hospital Berlin; 🇩🇪 Berlin, Germany