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
USC Medical Center
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Stanford University Medical Center
Stanford 5398563, California 5332921 94305
Stanford 5398563, California 5332921 94305
South Denver Cardiology Associates, PC
Littleton 5429032, Colorado 5417618 80120
Littleton 5429032, Colorado 5417618 80120
The Cardiac and Vascular Institute Research Foundation
Gainesville 4156404, Florida 4155751 32605
Gainesville 4156404, Florida 4155751 32605
Wellstar Kennestone Hospital
Marietta 4207783, Georgia 4197000 30060
Marietta 4207783, Georgia 4197000 30060
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
Mercy Hospital
Coon Rapids 5022025, Minnesota 5037779 55433
Coon Rapids 5022025, Minnesota 5037779 55433
St. Luke's Hospital of Kansas City
Kansas City 4393217, Missouri 4398678 64111
Kansas City 4393217, Missouri 4398678 64111
Columbia University Medical Center
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
St. Francis Hospital
Roslyn 5134415, New York 5128638 11576
Roslyn 5134415, New York 5128638 11576
Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
The Bronx 5110266, New York 5128638 10467
Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
Cleveland 5150529, Ohio 5165418 44195
UPMC Pinnacle
Mechanicsburg 5200657, Pennsylvania 6254927 17050
Mechanicsburg 5200657, Pennsylvania 6254927 17050
Baylor Heart & Vascular Hospital
Dallas 4684888, Texas 4736286 75226
Dallas 4684888, Texas 4736286 75226
The Methodist Hospital Research Institute
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
The Heart Hospital Baylor Plano
Plano 4719457, Texas 4736286 75093
Plano 4719457, Texas 4736286 75093
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
University of Virginia Medical Center
Charlottesville 4752031, Virginia 6254928 22908
Charlottesville 4752031, Virginia 6254928 22908
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
Detailed Description
The study will also contain a PK sub study and an IVUS sub study.