Comparing heart surgery and medical management for patients with aortic stenosis and coronary artery disease

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 study investigates the outcomes of patients with symptomatic aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) who also have coronary artery disease (CAD). It aims to determine the benefits and optimal timing of percutaneous coronary intervention (PCI) in conjunction with guideline-directed medical therapy. The study will compare a strategy of staged complete revascularization against medical management alone to assess which approach yields better patient outcomes. The findings will help clarify the management of CAD in patients receiving TAVR, especially as this procedure becomes more common in lower-risk populations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\- Symptomatic aortic valve stenosis prior to TAVR (NYHA Functional Class ≥ 2 OR Abnormal exercise test with severe SOB, abnormal BP response, or arrhythmia)

AND

\- CAD defined as: at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment ≥2.5 mm in diameter that is not a CTO and is amenable to treatment with PCI

AND

\- Consensus by the Local Multidisciplinary Heart Team that the patient is suitable for elective transfemoral TAVR with a balloon expandable transcatheter heart valve AND would receive a bypass with an anastomosis distal to the coronary artery lesion(s) if they were undergoing SAVR.

Local Multidisciplinary Heart Teams are expected to follow current clinical guidelines for selection of patients for TAVR with an eligible patient generally expected to have:

\[AVA ≤ 1.0 cm2 OR AVA index ≤ 0.6 cm2/m2\]

OR

\[Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg\]

OR

patients without these criteria may undergo TAVR if the Local Multidisciplinary Heart Team concludes it is appropriate.

AND

\- Successful transfemoral TAVR, defined as the implantation of a single transcatheter aortic valve within the past 96 hours with freedom from more than minimal aortic insufficiency, stroke, or major vascular complications.

Exclusion Criteria:

* PCI already performed within 90 days prior to TAVR or at the same time as the index transfemoral TAVR procedure
* Planned PCI of coronary artery lesion(s)
* Planned surgical revascularization of coronary artery lesion(s)
* Non-cardiovascular co-morbidity reducing life expectancy to \< 5 years
* Any factor precluding 5-year follow-up
* Prior coronary artery bypass grafting surgery or surgical valve replacement
* Severe mitral regurgitation (\> 3+)
* Severe left ventricular dysfunction (LVEF \< 30%)
* Low coronary takeoff (high risk for coronary obstruction)
* Acute myocardial infarction within 90 days
* Stroke or transient ischemic attack within 90 days
* Renal insufficiency (eGFR \< 30 ml/min) and/or renal replacement Rx
* Hemodynamic or respiratory instability

Where it's running

• Huntsville Heart Center
  Huntsville, Alabama, United States Recruiting
• Arizona Cardiovascular Research
  Phoenix, Arizona, United States Recruiting
• Veteran Affairs Palo Alto Health Care System
  Palo Alto, California, United States Recruiting
• Loma Linda University
  Redlands, California, United States Recruiting
• Santa Barbara Cottage Hospital
  Santa Barbara, California, United States Recruiting
• Torrance Memorial Medical Center
  Torrance, California, United States Recruiting

+22 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: David A Wood, MD — CCI-CIC, University of British Columbia
• Study coordinator: Brady J Robinson, CCRP
• Email: brobinson@cci-cic.org
• Phone: 604-875-4111

Similar studies

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

• PCI Registry at University Hospital Basel for Complex Coronary Procedures

  This registry collects real-world data from adults undergoing percutaneous coronary interventions at University Hospital Basel to see how different treatments like drug-eluting stents, drug-coated balloons, and bioresorbable scaffolds perform in diverse patients.

  Recruiting University Hospital, Basel, Switzerland · Basel, Canton of Basel-City · NCT07814157

• QFR-guided virtual stenting to optimize PCI before the procedure

  We’re testing whether using QFR-based virtual stenting before PCI can improve heart-procedure outcomes compared with standard angiography planning in adults with coronary artery disease.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07635407

• Single versus dual antiplatelet therapy after drug-coated balloon angioplasty in elderly or high-bleeding-risk patients

  This study tests whether taking one antiplatelet medicine is as safe and causes less bleeding than taking two medicines for people aged 75 or older, or adults at high bleeding risk, after drug-coated balloon angioplasty for coronary artery disease.

  Recruiting Fondazione Ricerca e Innovazione Cardiovascolare ETS · Milan, MI · NCT06535568

• AI platform for CT coronary angiography applications

  This study is testing a new AI platform that helps doctors quickly and accurately analyze heart scans for patients with coronary artery disease to improve their treatment and care.

  Recruiting at 3 sites National Heart Centre Singapore · Singapore and 2 other locations · NCT05509010

• 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

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.