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

A Prospective, Multicenter, Single Arm, Post-Approval Study of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females

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.

Study Overview

• Status: Terminated
• Conditions: Popliteal Artery Stenosis; Popliteal Artery Occlusion; Femoral Artery Occlusion; Femoral Artery Stenosis
• Intervention / Treatment: Device: Lutonix® 035 Drug Coated Balloon PTA Catheter

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Medical Group
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Vascular Access Solutions
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Device: Lutonix® 035 Drug Coated Balloon PTA Catheter; Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Number of Participants With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1, 6, 12, and 24 Months Post Index Procedure	1, 6, 12 and 24 months post index procedure
Number of Participants With Unanticipated and Anticipated Device Related Serious Adverse Events at 1, 6, 12, and 24 Months Post Index Procedure	1, 6, 12 and 24 months post index procedure
Number of Participants With Amputation (Above the Ankle)-Free Survival (AFS) at 1, 6, 12, and 24 Months Post Index Procedure.	1, 6, 12 and 24 months
Change in Rutherford Classification Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline	1, 6, 12 and 24 months post index procedure
Number of Participants With Sustained Clinical Benefit at 1, 6, 12, and 24 Months Post Index Procedure	1, 6, 12 and 24 months post index procedure
Change of Resting Ankle Brachial Index (ABI) Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline	1, 6, 12 and 24 months post index procedure

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Christopher Metzger, MD, Wellmont CVA Heart Institute

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2018
• Primary Completion (ACTUAL): February 18, 2019
• Study Completion (ACTUAL): February 18, 2019

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (ESTIMATE): June 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Experimental; Legs; Drug Coated Angioplasty Balloon; Standard Angioplasty Balloon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Arterial Occlusive Diseases; Constriction, Pathologic
• Other Study ID Numbers: CL0025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No