Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-10-21
2029-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Esprit BTK System
This device, manufactured by Abbott Medical, is intended to be used for improving luminal diameter in infrapopliteal lesions in patients with CLTI.
Esprit BTK System
The Esprit BTK System is a resorbable polymeric scaffold with the everolimus drug and a resorbable polymeric coating mounted on a balloon dilatation catheter.
Interventions
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Esprit BTK System
The Esprit BTK System is a resorbable polymeric scaffold with the everolimus drug and a resorbable polymeric coating mounted on a balloon dilatation catheter.
Eligibility Criteria
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Inclusion Criteria
1. Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first.
2. Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements.
2. Subject must be at least 18 years of age.
3. Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions.
1. Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter ≥ 2.5 mm and ≤ 4.0 mm.
2. Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography and intravascular imaging) can be used to aid accurate sizing of the vessels.
Exclusion Criteria
2. Subject is currently participating in another clinical investigation.
3. Subject is unable or unwilling to provide written consent prior to enrollment.
4. Subject with life expectancy ≤ 1 year.
5. Subject with an unsalvageable limb (as per physician assessment at the time of the index procedure), who is likely to get a below-the-knee amputation.
1. Subject has in-stent restenosis in the target vessel or requires treatment with a metallic stent in the target vessel during the index procedure.
2. Subject had been previously treated with Esprit BTK Scaffold(s).
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Ramon L Varcoe, MBBS, MS, FRACS, PHD
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Private Hospital, Randwick, NSW, Australia
Sahil Parikh, MD
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital, New York, NY
Brian G Derubertis, MD
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian/Cornell, New York, NY
Locations
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HonorHealth
Scottsdale, Arizona, United States
Pima Heart and Vascular Clinical Research
Tucson, Arizona, United States
UCSF Fresno
Fresno, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Ansaarie Cardiac and Endovascular Center of Excellence
Saint Augustine, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Grady Clinical Research Center
Atlanta, Georgia, United States
Archbold Medical Center
Thomasville, Georgia, United States
SIU School of Medicine
Springfield, Illinois, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Charlton Memorial Hospital
Fall River, Massachusetts, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
New York University Hospital
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
New York Presbyterian Hospital-Cornell University
New York, New York, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Staten Island University Hospital - North
Staten Island, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Christ Hospital
Cincinnati, Ohio, United States
Ascension St. John Jane Phillips
Bartlesville, Oklahoma, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Johnson City Medical Center Hospital
Johnson City, Tennessee, United States
Hendrick Medical Center
Abilene, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, United States
Park Plaza Hospital
Houston, Texas, United States
Queen Mary Hospital
Hong Kong, HK SAR, Hong Kong
Auckland City Hospital
Auckland, , New Zealand
Al Qassimi Hospital
Sharjah city, Ash Shāriqah, United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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[email protected]
Role: backup
Other Identifiers
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ABT-CIP-10519
Identifier Type: -
Identifier Source: org_study_id
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