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

NCT02813577 | Terminated Results FDA Device

• 1 other identifier: CL0025-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

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

Keywords

Legs; Drug Coated Angioplasty Balloon; Experimental; Standard Angioplasty Balloon

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Freedom From the Following: All-cause Peri-operative Death at 30 Days, Index Limb Amputation Within 1 Year, Index Limb Re-intervention Within 1 Year, and Index-limb-Related Death Within 1 Year Post Index Procedure

  Index limb amputation includes above or below the ankle amputations.

  12 months post index procedure

• Effectiveness: Number of Participants With Primary Patency of the Target Lesion at 12 Month Post Index Procedure.

  Primary patency is defined as freedom from target lesion restenosis (TLR) and from binary restenosis. Binary restenosis is adjudicated by the independent Core Laboratory based on Peak Systolic Velocity Ratio (PSVR) ≥ 2.5 and / or abnormal waveforms, or based on angiographic ≥ 50% diameter stenosis.

  12 months post index procedure

Secondary Outcomes (11)

• Number of Participants With Freedom From All-cause Perioperative (≤ 30 Day) Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-Limb-Related Death.

  30 days post index procedure

• Number of Major Vascular Complications at 30 Days Post Index Procedure

  30 days

• Number of Deaths (All Causes) at 30 Days Post Index Procedure

  30 days post index procedure

• Number of Participants With Clinically Driven Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Month Post Index Procedure

  1, 6, 12 and 24 months post index procedure

• Number of Participants With Target Vessel Revascularization (TVR) at 1, 6, 12, and 24 Months Post Index Porcedure

  1, 6, 12 and 24 months post index procedure

Study Arms (1)

Lutonix® 035 Drug Coated Balloon PTA Catheter

OTHER

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

Device: Lutonix® 035 Drug Coated Balloon PTA Catheter

Interventions

Lutonix® 035 Drug Coated Balloon PTA Catheter DEVICE

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

Lutonix® 035 Drug Coated Balloon PTA Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Life expectancy of \<2 years;
• 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;
• History of stroke within 3 months;
• History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of index procedure;
• Renal failure or chronic kidney disease with serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis;
• Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (4)

St. Vincent Medical Group

Indianapolis, Indiana, 46290, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Vascular Access Solutions

Orangeburg, South Carolina, 29118, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Related Links

• Lutonix® 035 Drug Coated Balloon PTA Catheter Instructions For Use

Results Point of Contact

• Title: Anna Lovas
• Organization: Becton Dickinson

anna.lovas@bd.com

763-445-2385

Study Officials

• Christopher Metzger, MD

  Wellmont CVA Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 27, 2016
• Study Start: April 20, 2018
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)