Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

NCT02063672 | Completed Results DMC

• 1 other identifier: CL0018-01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 20

Brief Summary

To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).

Conditions

Femoral Artery Stenosis; Femoral Artery Occlusion; Restenosis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Primary Patency at 1 Year

  Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.

  12 Months

• Percentage of Participants Without Primary Safety Events

  Primary Safety Events include: All Cause Perioperative (≤30 day) Death, Index Limb Amputation, Index Limb Reintervention and Index Limb Related Death at 1 Year

  12 Months

Secondary Outcomes (18)

• Percentage of Participants With Device Success

  During the Index Procedure (90 mins)

• Percentage of Participants With Technical Success

  During the Index Procedure (90 mins)

• Percentage of Participants With Procedural Success

  During the Index Procedure (90 mins)

• Percentage of Participants With Primary Patency at 6 and 12 Months

  6 months and 12 months

• Percentage of Participants With Secondary Patency at 6 Months and 12 Months

  6 months and 12 months

Study Arms (2)

Lutonix DCB

EXPERIMENTAL

Lutonix Paclitaxel Drug Coated Balloon

Device: Lutonix DCB

PTA Catheter

ACTIVE COMPARATOR

Standard Uncoated Balloon Angioplasty Catheter

Device: Standard Uncoated Balloon Angioplasty Catheter

Interventions

Lutonix DCB DEVICE

Lutonix DCB

Standard Uncoated Balloon Angioplasty Catheter DEVICE

PTA Catheter

PTA Catheter

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant female ≥18 years of age
• Rutherford Clinical Category 2-4
• Significant (≥ 50%) restenosis of a previous bare (not covered and not drug-eluting) nitinol stent(s) in the femoropopliteal artery
• Lesion measures between 4 and 18 cm
• Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix
• A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography
• Successful crossing and predilatation of the target lesion with a guidewire
• At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been (nor planned to be) revascularized
• No other prior vascular or surgical interventions within 2 weeks before and/or planned 30 days after the protocol treatment

You may not qualify if:

• Life expectancy of \<1 year
• Patient is currently participating in an investigational drug or other device study or previously enrolled in this study NOTE: Enrollment in another drug or device clinical trial during the follow up period is not allowed
• History of stroke within 3 months
• History of MI, thrombolysis or angina within 2 weeks of enrollment
• Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion
• Target lesion involves a previously placed covered stent or drug-eluting stent
• Grade 4 or 5 stent fracture (mal-aligned components or trans-axial spiral configuration) in the restenotic stent
• Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
• Known inadequate distal outflow (\>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion
• Intended use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, stents, etc.)

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (20)

Cardiology Associates

Fairhope, Alabama, 36532, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Radiology and Imaging Specialists of Lakeland, P.A.

Lakeland, Florida, 33805, United States

Location

Mount Sinai Medical Center

Miami, Florida, 33140, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

William Beaumont Hospital Research Institute

Royal Oak, Michigan, 48073, United States

Location

Metropolitan Hospital d/b/a Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Minneapolis Radiology and Vascular Research Foundation

Plymouth, Minnesota, 55441, United States

Location

Hattiesburg Clinic, PA

Hattiesburg, Mississippi, 39401, United States

Location

Jackson Heart Clinic, P.A.

Jackson, Mississippi, 39216, United States

Location

Kansas City Vascular Foundation

North Kansas City, Missouri, 64116, United States

Location

Hunterdon Cardiovascular Associates

Flemington, New Jersey, 08822, United States

Location

Rex Hospital, Inc.

Raleigh, North Carolina, 27607, United States

Location

TriHealth, Inc.

Cincinnati, Ohio, 45220, United States

Location

The Miriam Hospital - A Lifespan Partner

Providence, Rhode Island, 02906, United States

Location

Wellmont Cardiology Services, Inc.

Kingsport, Tennessee, 37660, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

Results Point of Contact

• Title: Heidi Ronhovde
• Organization: Lutonix

heidi.ronhovde@crbard.com

7634632900

Study Officials

• Carlos Mena, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 14, 2014
• Study Start: March 1, 2014
• Primary Completion: February 13, 2017
• Study Completion: March 1, 2019
• Last Updated: April 11, 2019
• Results First Posted: May 23, 2018

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)