Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-20

Study Completion Date

2019-02-18

Brief Summary

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The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix® Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two (2) years.

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Detailed Description

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The Lutonix® 035 Drug Coated Balloon PTA Catheter (Lutonix® Catheter) has been approved by the Food and Drug Administration (P130024) for percutaneous transluminal angioplasty, after appropriate vessel preparation of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm. The purpose of this post-approval study is to assess the safety and effectiveness of the Lutonix® Catheter in the US female population. This study will enroll approximately 165 female patients at a minimum of 10 US centers and a maximum of 25.

Conditions

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Femoral Artery Stenosis Popliteal Artery Stenosis Femoral Artery Occlusion Popliteal Artery Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lutonix® 035 Drug Coated Balloon PTA Catheter

This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Group Type OTHER

Lutonix® 035 Drug Coated Balloon PTA Catheter

Intervention Type DEVICE

Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Interventions

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Lutonix® 035 Drug Coated Balloon PTA Catheter

Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

1. Life expectancy of \<2 years;
2. Subject is currently participating in an investigational drug or device study, or previously enrolled in this study. Enrollment in another investigational drug or device study during the follow up period is not allowed;
3. History of stroke within 3 months;
4. History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of index procedure;
5. Renal failure or chronic kidney disease with serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis;
6. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No