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
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
Detailed Description
The study will also contain a PK sub study and an IVUS sub study.