AGENT drug-coated balloon versus standard PCI for de novo coronary lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter, open-label, randomized 1:1 study compares a treatment strategy using the AGENT drug-coated balloon (DCB) to standard percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and/or balloon angioplasty in adults with de novo lesions in native coronary arteries. Subjects with a pre-dilatable target lesion that meets angiographic stenosis criteria will be randomized to AGENT DCB or standard of care. The protocol includes pharmacokinetic and intravascular ultrasound (IVUS) substudies and requires follow-up visits to monitor safety and effectiveness outcomes. Enrollment and procedures take place at selected centers in Southern California and include a 12-month contraception requirement for women of child-bearing potential.

Why it matters

Who can join: the full rules

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.) 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/mm3.
* 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.

Where it's running

• Honor Health
  Scottsdale, Arizona, United States Recruiting
• St. Bernard's Medical Center
  Jonesboro, Arkansas, United States Recruiting
• Scripps Memorial Hospital
  La Jolla, California, United States Recruiting
• USC Medical Center
  Los Angeles, California, United States Recruiting
• Cedars - Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: David Kandzari — Piedmont Heart Institute
• Study coordinator: Beth Lawson
• Email: beth.lawson@bsci.com
• Phone: 508-683-6560

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Red grape juice and metabolism in men with coronary disease

  Researchers will test whether daily red grape juice changes the blood metabolite profile in men with chronic coronary artery disease.

  Recruiting University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07777341

• Edoxaban vs. Apixaban in AF with CAD: Net Benefit

  This trial tests whether edoxaban-based therapy provides a similar or better overall benefit than apixaban-based therapy for stroke prevention and major bleeding in adults with atrial fibrillation and coronary artery disease.

  Recruiting Phase 4 Samsung Medical Center · Seoul · NCT07753200

• Revascularization of Calcified Coronary Arteries

  This study tests whether measuring blood flow and pressure before and after ballooning or stenting of calcified coronary arteries can help predict how well the procedure will work for adults with heart disease.

  Recruiting Aalborg University Hospital · Aalborg · NCT07724184

• OPN Balloon Use for Recanalization of Calcified Coronary Lesions

  This registry tests how the SIS-OPN balloon is used in real-world patients with calcified coronary disease who have undergone PCI in North America.

  Recruiting Minneapolis Heart Institute Foundation · Minneapolis, Minnesota · NCT07646444

• Pulse IVL to open calcified coronary vessels in CAD

  A small, early feasibility study tests the Pulse Intravascular Lithotripsy system in adults with coronary artery disease to see if it can safely open calcified arteries and improve vessel compliance.

  Recruiting at 4 sites Amplitude Vascular Systems, Inc. · Sydney, New South Wales and 3 other locations · NCT07510438

• Crystalline sirolimus-coated balloon for treating coronary artery disease

  This tests whether a crystalline sirolimus-coated balloon is safe and effective for adults having percutaneous coronary intervention for coronary artery blockages or in-stent restenosis.

  Recruiting Fundación Interhospitalaria para la Investigación Cardiovascular FIC · Vigo, Pontevedra · NCT07444957

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.