AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,616
- Locations
- 82
- Primary Endpoint
- Target Lesion Failure (TLF) rate
Study Overview
Brief Summary
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.
Detailed Description
The study will also contain a PK sub study and an IVUS sub study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Where possible, independent outcome assessors will be masked.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical 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.
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.) as assessed by Investigator.
- •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% within the last 12 months.
- •Subject had PCI or other coronary interventions within the last 3 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 ACS 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/mm
- •Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent).
- •Subject has previous or planned (within 30 days) TAVR.
- •Previous cardiac transplant.
- •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 or requires intravascular lithotripsy.
- •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 <3 mm from aorta.
- •Target Lesion is in a previously jailed side branch.
Arms & Interventions
Bifurcation - Control
Bifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty
Intervention: Drug eluting stent (Device)
Overall - Test
All subjects treated with AGENT DCB
Intervention: Drug Eluting Balloon (Device)
Long Lesion - Test
Long lesion subjects treated with AGENT DCB
Intervention: Drug Eluting Balloon (Device)
Small Vessel - Test
Small vessel subjects treated with AGENT DCB
Intervention: Drug Eluting Balloon (Device)
Small Vessel - Control
Small vessel subjects treated with drug eluting stent
Intervention: Drug eluting stent (Device)
Bifurcation - Control
Bifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty
Intervention: Plain old balloon angioplasty (Procedure)
Long Lesion - Control
Long lesion subjects treated with drug eluting stent
Intervention: Drug eluting stent (Device)
Overall - Control
All subjects treated with standard of care drug eluting stent and/or POBA
Intervention: Plain old balloon angioplasty (Procedure)
Bifurcation - Test
Bifurcation subjects with side branches treated with AGENT DCB
Intervention: Drug Eluting Balloon (Device)
Overall - Control
All subjects treated with standard of care drug eluting stent and/or POBA
Intervention: Drug eluting stent (Device)
Outcomes
Primary Outcomes
Target Lesion Failure (TLF) rate
Time Frame: 12-Month
Target Lesion Failure (TLF) rate - defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death. The MI events include the Peri-Procedural MI (PPMI) according to the SCAI MI definition and the spontaneous MI according to the 4th Universal MI definition.
Secondary Outcomes
No secondary outcomes reported