A Prospective, Multi-Center, Single-Arm Trial to Assess the Safety and Feasibility of the SurModics Drug Coated Balloon in the Treatment of Subjects With De Novo Lesions of the Femoropopliteal Artery

SurModics, Inc.3 sites in 1 country13 target enrollmentApril 5, 2016

ConditionsPeripheral Arterial Disease Peripheral Vascular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: SurModics, Inc.
Enrollment: 13
Locations: 3
Primary Endpoint: Peak paclitaxel plasma concentration
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and popliteal arteries. The trial will enroll up to 15 subjects.

Detailed Description

PREVEIL will enroll patients presenting with angiographic evidence of significant stenosis in the femoral or popliteal arteries. All enrolled subjects will be treated with the SurVeil DCB.

Registry

clinicaltrials.gov

Start Date

April 5, 2016

End Date

February 11, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

SurModics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following criteria to participate in the trial:
•Subject is ≥ 18 years.
•Subject has lifestyle-limiting claudication or rest pain with Rutherford classification 2, 3 or
•Subject has provided written informed consent.
•Subject is willing to comply with study follow-up requirements.
•A de novo target lesion in the femoral or popliteal arteries.
•Target lesion must have angiographic evidence of ≥ 50% stenosis by operator visual estimate.
•Target lesion must be ≤ 90 mm in length (one long lesion or multiple serial lesions) by operator visual estimate. Note: Multiple serial lesions are allowed provided that they can be treated as a single lesion with one balloon.
•Target vessel must have an reference vessel diameter (RVD) of 4 mm to 6 mm by operator visual estimate.
•After pre-dilatation, the target lesion is ≤ 70% residual stenosis, absence of a flow limiting dissection and treatable with a single balloon (lesion length ≤90 mm, limited to 100-mm balloon in EFS).

Exclusion Criteria

•Subjects will be excluded from the trial if any of the following criteria are met:
•Subject has acute limb ischemia.
•Subject has Rutherford classification of 0, 1, 5 or
•Subject previously underwent any lower extremity percutaneous transluminal angioplasty (PTA) using a DCB within 3 months.
•Subject has had prior vascular intervention within 2 weeks before the planned study index procedure or subject has planned vascular intervention within 30 days after the study index procedure.
•Subject is pregnant and/or breast-feeding or intends to become pregnant during the time of the study OR subject is a male intending to father children within 60 days of index procedure.
•Life expectancy less than 2 years.
•Subject has a known allergy to contrast medium that cannot be adequately pre-medicated.
•Subject is allergic to ALL antiplatelet treatments.
•Subject has impaired renal function (i.e. serum creatinine level ≥ 2.5 mg/dl).

Outcomes

Primary Outcomes

Peak paclitaxel plasma concentration

Time Frame: Up to 30 days

Paclitaxel plasma levels will be assessed at baseline, immediately post-index procedure, at 1h, 2h, 4h, 12h (or upon discharge), and 30 days post-index procedure.

Secondary Outcomes

Embolic events of the index limb(30 days, 6, 12, 24, and 36 months)
Evidence of Paclitaxel toxicity(At hospital discharge, 30 days)
Major adverse events(30 days, 6, 12, 24, and 36 months)
Index limb above the ankle amputation(30 days, 6, 12, 24, and 36 months)
Major vascular complications(At hospital discharge, 30 days)
Resting ankle brachial index(within 90 days of index procedure, and at 6, 12, 24 and 36 months post-index procedure)
Change in 6-minute walk test(baseline, 30 days, 6, 12, 24, and 36 months)
Continuous DUS Peak systolic velocity ratio (PSVR) as measured by Duplex ultrasound(30 days, 6, 12, 24, and 36 months)
Late lumen loss(baseline, 6 months)
Quality of life(baseline, 30 days, 6, 12, 24, and 36 months)
Clinically-driven TLR(30 days, 6, 12, 24, and 36 months)
Clinically-driven target vessel revascularization (TVR)(30 days, 6, 12, 24, and 36 months)
Area under the drug concentration time curve(Up to 30 days)
Technical success(At procedure)
Device success(At procedure)
Procedure success(At procedure up to 12 hours)
Primary patency(6 months)
Thrombolysis in Myocardial Infarction (TIMI)-defined major and minor bleeding(At hospital discharge, 30 days)
All-cause death(30 days, 6, 12, 24, and 36 months)
Change in Rutherford classification(baseline, 30 days, 6, 12, 24, and 36 months)
Index limb below the ankle amputation(30 days, 6, 12, 24, and 36 months)
Arterial thrombosis of the treated segment on angiography(30 days, 6, 12, 24, and 36 months)