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

Boston Scientific

Status: Begins enrollment in 3 months

Conditions: Coronary Arterial Disease (CAD); de Novo Lesions in Native Coronary Arteries

Treatments: Device: Drug eluting stent; Procedure: Plain old balloon angioplasty; Device: Drug Eluting Balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT06959524

S2530

Details and patient eligibility

About

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.

Full description

The study will also contain a PK sub study and an IVUS sub study.

Enrollment: 1,328 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,328 participants in 8 patient groups

Small Vessel - Test

Experimental group

Description:

Small vessel subjects treated with AGENT DCB

Treatment:

Device: Drug Eluting Balloon

Small Vessel - Control

Active Comparator group

Description:

Small vessel subjects treated with drug eluting stent

Treatment:

Device: Drug eluting stent

Bifurcation - Test

Experimental group

Description:

Bifurcation subjects with side branches treated with AGENT DCB

Treatment:

Device: Drug Eluting Balloon

Bifurcation - Control

Active Comparator group

Description:

Bifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty

Treatment:

Procedure: Plain old balloon angioplasty

Device: Drug eluting stent

Long Lesion - Test

Experimental group

Description:

Long lesion subjects treated with AGENT DCB

Treatment:

Device: Drug Eluting Balloon

Long Lesion - Control

Active Comparator group

Description:

Long lesion subjects treated with drug eluting stent

Treatment:

Device: Drug eluting stent

Overall - Test

Experimental group

Description:

All subjects treated with AGENT DCB

Treatment:

Device: Drug Eluting Balloon

Overall - Control

Active Comparator group

Description:

All subjects treated with standard of care drug eluting stent and/or POBA

Treatment:

Procedure: Plain old balloon angioplasty

Device: Drug eluting stent