Coronary Arterial Disease study: Drug Eluting Balloon vs Drug eluting stent
Official title 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
ClinicalTrials.gov ID: NCT06959524
What this study is testing
- What it's testing
- The study wants to find out if the AGENT drug‑coated balloon is safe and works as well as the usual PCI (stent or balloon) for new coronary lesions.
- Who it's for
- Adults who have a new (de novo) blockage in a native coronary artery.
- What's involved
- Participants are randomly assigned to receive either the AGENT drug‑coated balloon or the standard PCI with a drug‑eluting stent or balloon angioplasty, followed by scheduled medical visits and tests.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical
- 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...
- Subject is eligible for percutaneous coronary intervention (PCI).
- Subject is willing to comply with all protocol-required follow-up evaluation.
You likely can't join if
- 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...
See the full eligibility criteria
- Clinical
- 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
- Target lesion is a de novo lesion located in a native coronary artery.
- Target lesion must have visually estimated stenosis \> 50% and \ 70% and \<100% in asymptomatic people) 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
- 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 \ 700k/mm3.
- Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent).
- Subject has previous or planned (within 30 days) TAVR.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Jonesboro, Arkansas, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Thousand Oaks, California, United States
- Littleton, Colorado, United States
- Gainesville, Florida, United States
- Miami Beach, Florida, United States
- Atlanta, Georgia, United States
- Marietta, Georgia, United States
- Evanston, Illinois, United States
- Glenview, Illinois, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Coon Rapids, Minnesota, United States
- Kansas City, Missouri, United States
+ 43 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Jonesboro, Arkansas, United States; La Jolla, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Stanford, California, United States and 57 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.