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

C. R. Bard

Status: Terminated

Conditions: Femoral Artery Occlusion; Popliteal Artery Occlusion; Popliteal Artery Stenosis; Femoral Artery Stenosis

Treatments: Device: Lutonix® 035 Drug Coated Balloon PTA Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02813577

CL0025-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Clinical Criteria

1. Non-pregnant female ≥18 years of age;

2. Rutherford Clinical Category 2-4;

3. Patient is willing to provide informed consent, is geographically stable, comply with the required follow up visits and testing schedule;

   Angiographic Criteria

4. De novo or restenotic lesion(s) in native superficial femoral or popliteal arteries;

5. Lesion ≥70% stenosis by visual estimate;

6. Target reference vessel diameter of 4-7 mm;

7. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography; (Treatment of target lesion acceptable after successful treatment of inflow artery lesions. Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.)

8. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography after successful vessel preparation;

9. Successful antegrade wire crossing and vessel preparation (may include pre-dilatation) of the target lesion. Successful vessel preparation is defined by residual stenosis ≤30% without any major vascular complications;

10. No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment except for remote common femoral patch angioplasty separated by at least 2 cm from the lesion(s).

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4 participants in 1 patient group

Lutonix® 035 Drug Coated Balloon PTA Catheter

Other group

Description:

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

Treatment:

Device: Lutonix® 035 Drug Coated Balloon PTA Catheter