LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial

Status: Active, not recruiting
Location: See all (56) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed infrapopliteal lesions. Approximately 225 subjects will be randomized in a 2:1 ratio. The clinical investigation will be conducted at approximately 65 clinical sites in the US, Asia, Australia, and New Zealand.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Subject must provide written informed consent prior to any clinical investigation related procedure.

• Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5.

• Subject requires primary treatment of up to two de novo or restenotic (treated with prior PTA) infrapopliteal lesions.

• Subject must be at least 18 years of age.

• Female subject of childbearing potential should not be pregnant and must be on birth control.

• Note: Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

• Anatomic Inclusion Criteria:

• Up to two native infrapopliteal lesions, each lesion located in separate infrapopliteal vessel in the same limb. Restenotic (from prior PTA) lesions are allowed.

• Lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with vessel diameter of ≥ 2.5 mm and ≤ 4.00 mm by investigator visual assessment.

• Total scaffold length to completely cover/treat a target lesion must not exceed 170 mm (total everolimus drug dose of 1790 µg).

• The total scaffold length among all target lesions must not exceed 170 mm.

• The target vessel cannot have any other angiographic significant lesions (≥50%).

• Tandem lesions are allowed if they are < 3 cm apart and the total scaffold length used to cover the entire diseased segment is ≤ 170 mm. Each tandem lesion is considered one lesion.

• Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography, IVUS, and/or OCT) can be used to aid accurate sizing of the vessels.

• The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise. The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis).

• Significant lesion (≥ 50% stenosis) in the inflow artery(ies) must be treated successfully (as per physician's assessment of the angiography) through standard of care prior to the treatment of the target lesion. Treatment can be done within the same trial procedure.

• Non-target lesion(s) (if applicable) must be located in separate infrapopliteal vessel(s) from the target lesion, and suitable to be treated per institution standard of care.

• Guidewire must cross the target lesion successfully. Crossing in an antegrade fashion is preferred, but retrograde crossing may be used. However, the treatment must be delivered antegrade.

Locations
United States
Arkansas
Arkansas Heart Hospital
Little Rock
Arizona
Comprehensive Integrated Care
Gilbert
California
St. Helena Hospital
Deer Park
Mission Cardiovascular Research Institute
Fremont
UCSF Fresno
Fresno
St. Joseph Hospital
Orange
Colorado
University of Colorado Hospital
Aurora
Connecticut
Yale New Haven Hospital
New Haven
Florida
Manatee Memorial Hospital
Bradenton
First Coast Cardiovascular Institute
Jacksonville
Palm Vascular Centers
Miami Beach
Tallahassee Research Institute
Tallahassee
Georgia
Piedmont Heart Institute
Atlanta
Iowa
The Iowa Clinic
West Des Moines
Illinois
University of Chicago Medical Center
Chicago
Kansas
Via Christi Regional Medical Center - St. Francis Campus
Wichita
Louisiana
Cardiovascular Institute of the South
Houma
Massachusetts
St. Elizabeth's Medical Center
Boston
Charlton Memorial Hospital
South Dartmouth
Mississippi
Jackson Heart Clinic
Jackson
North Carolina
NC Heart & Vascular Research
Raleigh
Coastal Carolina Surgical Associates
Wilmington
New Jersey
Deborah Heart & Lung Center
Browns Mills
Hackensack University Medical Center
Hackensack
Vascular Institute of Atlantic Medical Imaging
Pomona
Holy Name Medical Center
Teaneck
New York
James J. Peters VA Medical Center
Bronx
Mount Sinai Hospital
New York
New York Presbyterian Hospital/Cornell University
New York
New York-Presbyterian/Columbia University Medical Center
New York
NYU Langone Health
New York
Ohio
The Lindner Center
Cincinnati
The Cleveland Clinic Foundation
Cleveland
University Hospitals Cleveland Medical Center
Cleveland
Oklahoma
Ascension St. John Jane Phillips
Bartlesville
Pennsylvania
Lankenau Institute for Medical Research
Bryn Mawr
Saint Vincent Consultants in Cardiovascular Diseases
Erie
University of Pittsburgh Medical Center
Pittsburgh
Pinnacle Health System
Wormleysburg
South Carolina
Anmed Health
Anderson
Medical University of South Carolina
Charleston
Tennessee
Wellmont CVA Heart Institute
Kingsport
Texas
University of Texas Southwestern Medical Center at Dallas
Dallas
Baylor All Saints Medical Center at Fort Worth
Fort Worth
Texas Tech University Health Sciences Center at Lubbock
Lubbock
Texas Health Resources Presbyterian Plano
Plano
San Antonio Vascular and Endovascular Clinic
San Antonio
Other Locations
Australia
Sir Charles Gairdner Hospital
Nedlands
Prince of Wales Private Hospital
Randwick
Royal North Shore Hospital
Sydney
Hong Kong Special Administrative Region
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
New Zealand
Auckland City Hospital
Auckland
Singapore
Changi General Hospital
Singapore
Taiwan
Taipei Tzu Chi Hospital
New Taipei City
National Taiwan University Hospital
Taipei City
Time Frame
Start Date: August 18, 2020
Estimated Completion Date: July 2027
Participants
Target number of participants: 261
Treatments
Experimental: Esprit BTK
Participants who receives Esprit BTK device will be included in this arm
Active Comparator: Percutaneous Transluminal Angioplasty (PTA)
Participants who receives PTA treatment will be included in this arm
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov

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