IVUS-Guided PCI in minority patients with complex coronary disease registry

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 is a multicenter, prospective registry enrolling up to 1010 adults over two years to observe outcomes after IVUS-guided PCI for complex coronary lesions. It focuses on safety and clinical outcomes in a US minority population. All participants receive IVUS-guided PCI using FDA-approved drug-eluting stents or drug-coated balloons, with follow-up through 2 years. The study is observational and single-arm, without randomization. Enrollment spans multiple centers including Banner Health, Loma Linda University Health, and Baptist Health, with support from ECRI bv and industry collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The patient must be ≥18 years of age and self-identify within a US census-defined minority
2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:

   1. Angiographic heavy calcification
   2. Ostial lesions
   3. True bifurcation lesions involving side-branches \>2.5mm
   4. Left main lesions
   5. Chronic total occlusion
   6. In-stent restenosis
   7. Long-lesions (estimated stent length \> 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI
3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
4. All lesions must be suitable for treatment with FDA-approved contemporary generation drug eluting stents or drug-coated balloons
5. The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she (or an authorized legal representative) provides informed consent prior to any protocol-related procedure, as approved by the appropriate IRB

Exclusion Criteria:

1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
2. Known untreated severe valvular heart disease
3. Contraindication on the use of IVUS (i.e. extreme vessel tortuosity)
4. Requiring PCI in a diseased aorto-coronary bypass
5. Known contraindication or hypersensitivity to anticoagulants
6. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
7. Non-cardiac co-morbidities with a life expectancy less than 1 year
8. A patients that is currently participating in a clinical trial that has not yet reached its primary endpoint cannot be included in this registry. A patient may only be enrolled in this registry once.

Where it's running

• Banner Health
  Phoenix, Arizona, United States Recruiting
• Loma Linda University Health
  Loma Linda, California, United States Recruiting
• Baptist Health
  Coral Gables, Florida, United States Recruiting
• Advent Health
  Tampa, Florida, United States Recruiting
• Cleveland Clinic Florida
  Weston, Florida, United States Recruiting
• Emory University Hospital Midtown
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: David E Kandzari, MD — Piedmont Heart Institute
• Study coordinator: Chantal Bakker
• Email: CBakker@cardialysis.nl
• Phone: 31+102062828

Similar studies

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

• μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease

  This trial tests whether using computational μFR guidance during drug-coated balloon angioplasty is better than standard angiography guidance for people with de novo coronary artery lesions.

  Recruiting Centro Cardiologico Monzino · Cosenza, CS and 3 other locations · NCT07917234

• Gastric Ultrasound Before CABG to See if Heart Function Changes Stomach Contents

  This study checks whether people with weaker heart function before elective CABG have different stomach contents seen on ultrasound.

  Recruiting Adiyaman University · Adıyaman · NCT07898215

• Can preoperative photon-counting CT help predict heart recovery after bypass surgery?

  This observational study tests whether a preoperative photon-counting CT can help predict heart function 3 months after coronary bypass surgery in adults with coronary artery disease.

  Recruiting Chinese PLA General Hospital · Beijing · NCT07883499

• Real-World Drug-Coated Balloon Angioplasty in Coronary Artery Disease

  This registry tests how drug-coated balloons perform in everyday clinical practice for adults with coronary artery disease undergoing PCI.

  Recruiting at 5 sites Hospital Arnau de Vilanova · Mexico City, Mexico City and 4 other locations · NCT07875088

• Predicting vasopressor needs after anesthesia in elective on-pump CABG using dynamic arterial elastance

  This study tests whether EaDyn measured after induction can help predict which patients will need vasopressors during elective on-pump CABG.

  Recruiting University of Gaziantep · Gaziantep · NCT07871201

• Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in CABG Patients

  This study tests whether the amount a patient’s pulse pressure varies during surgery relates to how quickly lactate levels drop after CABG.

  Recruiting University of Gaziantep · Gaziantep · NCT07871188

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.