AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions
Purpose
AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and/or balloon angioplasty in patients with de novo coronary lesions. Subjects must have a de novo target lesion located in a native coronary artery.
Conditions
- Coronary Arterial Disease (CAD)
- de Novo Lesions in Native Coronary Arteries
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subject must be at least 18 years of age. - Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. - Subject is eligible for percutaneous coronary intervention (PCI). - Subject is willing to comply with all protocol-required follow-up evaluation. - Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure. Angiographic Inclusion Criteria: - Target lesion is a de novo lesion located in a native coronary artery - Target lesion must have visually estimated stenosis > 50% and < 100% in symptomatic subjects (>70% and <100% in asymptomatic subjects) prior to lesion pre-dilation. - Target lesion must be successfully pre-dilated. - If a non-target lesion is treated, it must be treated first and must be deemed a success. Clinical
Exclusion Criteria
- Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 12 months. - Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.). - Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation. - Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint. - Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure. - Subject is a woman who is pregnant or nursing. A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential. - Subject has left ventricular ejection fraction known to be < 30%. - Subject had PCI or other coronary interventions within the last 30 days. - Subject has planned PCI or CABG after the index procedure. - Subject had STEMI or QWMI <72h prior to the index procedure. - Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically unstable. - Subject has cardiogenic shock (SBP < 80 mmHg requiring inotropes, IABP or fluid support). - Subject has history (within 6 months prior to the index procedure) of New York Heart Association (NYHA) class III or IV heart failure. - Subject is considered not able to tolerate at least 30 seconds of coronary occlusion of the target lesion. - Subject has known allergy to paclitaxel or other components of the used medical devices. - Subject has known hypersensitivity or contraindication to contrast dye that in the opinion of the investigator cannot be adequately pre-medicated. - Subject has intolerance to antiplatelet drugs, anticoagulants required for procedure. - Subject has platelet count < 100k/mm3 (risk of bleeding) or > 700k/mm3. - Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent). Angiographic Exclusion Criteria: - In-stent restenosis. - Target lesion is located within a saphenous vein or arterial graft. - Target lesion is a total occlusion or has evidence of thrombus present in the target vessel. - Target lesion is severely calcified by angiography or has > 270° calcium arc on intravascular imaging or requires atherectomy. - Subject has unprotected left main coronary artery disease (>50% diameter stenosis) or three-vessel coronary disease requiring revascularization of all 3 vessels. - Subject with planned treatment of lesion involving aortic ostial location.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Where possible, independent outcome assessors will be masked.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Small Vessel - Test |
Small vessel subjects treated with AGENT DCB |
|
|
Active Comparator Small Vessel - Control |
Small vessel subjects treated with drug eluting stent |
|
|
Experimental Bifurcation - Test |
Bifurcation subjects with side branches treated with AGENT DCB |
|
|
Active Comparator Bifurcation - Control |
Bifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty |
|
|
Experimental Long Lesion - Test |
Long lesion subjects treated with AGENT DCB |
|
|
Active Comparator Long Lesion - Control |
Long lesion subjects treated with drug eluting stent |
|
|
Experimental Overall - Test |
All subjects treated with AGENT DCB |
|
|
Active Comparator Overall - Control |
All subjects treated with standard of care drug eluting stent and/or POBA |
|
Recruiting Locations
Scripps Memorial Hospital
La Jolla, California 92037
La Jolla, California 92037
USC Medical Center
Los Angeles, California 90033
Los Angeles, California 90033
Cedars - Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
University of California San Francisco
San Francisco, California 94143
San Francisco, California 94143
Stanford University Medical Center
Stanford, California 94305
Stanford, California 94305
Los Robles Hospital & Medical Center
Thousand Oaks, California 91360
Thousand Oaks, California 91360
South Denver Cardiology Associates, PC
Littleton, Colorado 80120
Littleton, Colorado 80120
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida 32605
Gainesville, Florida 32605
Mount Sinai Medical Center
Miami Beach, Florida 33140
Miami Beach, Florida 33140
Piedmont Hospital
Atlanta, Georgia 30309
Atlanta, Georgia 30309
Emory University Hospital
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Wellstar Kennestone Hospital
Marietta, Georgia 30060
Marietta, Georgia 30060
Endeavor Health
Glenview, Illinois 60026
Glenview, Illinois 60026
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
University of Michigan Hospitals
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
Corewell Health
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
St. Luke's Hospital of Kansas City
Kansas City, Missouri 64111
Kansas City, Missouri 64111
NYU Langone Hospital
Brooklyn, New York 11220
Brooklyn, New York 11220
Mount Sinai Medical Center
New York, New York 10029
New York, New York 10029
Columbia University Medical Center
New York, New York 10032
New York, New York 10032
St. Francis Hospital
Roslyn, New York 11576
Roslyn, New York 11576
Montefiore Medical Center
The Bronx, New York 10467
The Bronx, New York 10467
Carolinas Medical Center
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Cleveland Clinic Foundation
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Ohio Health Riverside Methodist Hospital
Columbus, Ohio 43214
Columbus, Ohio 43214
Providence St. Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
UPMC Pinnacle
Mechanicsburg, Pennsylvania 17050
Mechanicsburg, Pennsylvania 17050
York Hospital
York, Pennsylvania 17403
York, Pennsylvania 17403
Rhode Island Hospital
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Prisma Health Richland Hospital
Columbia, South Carolina 29203
Columbia, South Carolina 29203
Baylor Heart & Vascular Hospital
Dallas, Texas 75226
Dallas, Texas 75226
The Methodist Hospital Research Institute
Houston, Texas 77030
Houston, Texas 77030
The Heart Hospital Baylor Plano
Plano, Texas 75093
Plano, Texas 75093
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas 78229
San Antonio, Texas 78229
University of Virginia Medical Center
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Inova Fairfax Hospital
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Charleston Area Medical Center
Charleston, West Virginia 25304
Charleston, West Virginia 25304
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
Detailed Description
The study will also contain a PK sub study and an IVUS sub study.