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Recruiting NCT06959524

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

No phase Interventional Coronary Arterial Disease (CAD) de Novo Lesions in Native Coronary Arteries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drug Eluting Balloon, Drug eluting stent, Plain old balloon angioplasty.
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, China, Germany, Ireland +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 46 centers
  • Scripps Memorial Hospital — La Jolla
  • USC Medical Center — Los Angeles
  • Cedars - Sinai Medical Center — Los Angeles
  • University of California San Francisco — San Francisco
  • Stanford University Medical Center — Stanford
  • Los Robles Hospital & Medical Center — Thousand Oaks
  • South Denver Cardiology Associates, PC — Littleton
  • The Cardiac and Vascular Institute Research Foundation — Gainesville
  • … and 38 more centers
China · 5 centers
  • Beijing Anzhen Hospital of the Capital University of Medical Sciences — Beijing
  • Fuwai Hospital Chinese Academy of Medical Sciences — Beijin
  • The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
  • Wuhan Asia Heart Hospital — Wuhan
  • The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
Germany · 3 centers
  • Cellitinnen Krankenhaus St. Vinzenz — Cologne
  • MEDICLIN Herzzentrum Lahr — Lahr
  • Krankenhaus der Barmherzigen Brüder — Trier
Ireland · 3 centers
  • Mater Private Hospital Cork — Cork
  • Mater Private Hospital — Dublin
  • Galway University Hospital — Galway
Japan · 3 centers
  • Medical Corporation Sapporo Heart Center Sapporo Cardiovascular Clinic — Sapporo
  • Kyorin University Hospital — Mitaka
  • Chikamori Hospital — Kochi
Spain · 3 centers
  • Hospital Universitario de La Princesa — Madrid
  • Hospital Universitario y Politécnico La Fe — Valencia
  • Clínico de Valladolid — Valladolid
Australia · 2 centers
  • The Prince Charles Hospital — Chermside
  • Victorian Heart Hospital — Clayton
New Zealand · 1 center
  • Auckland City Hospital — Auckland
South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT06959524 · S2530

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗