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

Conditions

• Coronary Arterial Disease (CAD)
• de Novo Lesions in Native Coronary Arteries

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Drug Eluting Balloon — DEVICE
  AGENT DCB
• Drug eluting stent — DEVICE
  Any commercially available DES used for standard of care.
• Plain old balloon angioplasty — PROCEDURE
  Bifurcation side branch - POBA

Study Details

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.

Key Dates

Start date

Aug 21, 2025

Status verified

Jun 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2032

Study Design

Enrollment

1,616 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Target Lesion Failure (TLF) rate [ Time Frame: 12-Month ]

Central Contacts

• Beth Lawson
  508-683-6560
  [email protected]
• Kim Pena-Trast
  904-314-4269
  [email protected]

Locations (42)

Find similar trials in La Jolla, CA

Related Studies

• The Switching Antiplatelet-9 (SWAP-9) Study
  PHASE4 · Recruiting · University of Florida · Jacksonville, Florida
• FORWARD CAD IDE Study
  Recruiting · Shockwave Medical, Inc. · La Jolla, California
• Focused Orticumab Research for Treating Inflammation in Coronary Arteries
  PHASE2 · Recruiting · Abcentra · Los Angeles, California
• Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
  PHASE4 · Recruiting · University of Florida · Jacksonville, Florida