Comparing PCI and medical therapy for chronic total occlusion in heart 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 clinical trial investigates the effectiveness of Percutaneous Coronary Intervention (PCI) using the latest drug-eluting stents compared to optimal medical therapy (OMT) in patients with chronic total occlusion (CTO) of coronary arteries. It is a prospective randomized open-label multicenter study that includes both asymptomatic and symptomatic patients with varying degrees of myocardial ischemia. Patients will undergo three months of OMT before being randomized into treatment groups, with outcomes measured in terms of major adverse cardiovascular events and quality of life improvements. The study aims to provide clearer evidence on the benefits of PCI in managing CTO.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* CTO in native coronary artery
* Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.
* Age ≥18 yrs.
* Able to provide written informed consent and willing to comply with the specified follow-up contacts.
* Target artery ≥ 2.5 mm

Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into:

Cohort A: Asymptomatic (CCS \< 2 and SAQ QoL \> 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO

Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO assess by nuclear imaging.

Cohort C: Screening population not eligible for randomization in cohort A or B

Exclusion Criteria:

* NSTEMI or STEMI within 1 month
* Coronary anatomy not suitable for CTO-procedure
* Coronary disease involving the left main/three vessel disease with indication for CABG following heart team conference.
* Life expectancy \< 2 years
* Severe chronic pulmonary disease (FEV1 \< 30 % of predicted value)
* Contraindication to dual anti-platelet therapy
* Pregnancy
* eGFR \< 30 mL/min/1.73 m2
* In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.
* Severe valvular heart disease

Where it's running

• Aarhus University Hospital
  Aarhus N, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Gentofte Hospital
  Hellerup, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting
• Zealand University Hospital
  Roskilde, Denmark Recruiting
• North-Estonia Medical Centre
  Tallinn, Estonia Recruiting

Study contacts

• Principal investigator: Evald Christiansen, MD PhD — Aarhus University Hospital
• Study coordinator: Evald Christiansen, MD PhD
• Email: evald.christiansen@dadlnet.dk
• Phone: +45 78452028

Similar studies

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

• Outpatient Cardiac Telerehabilitation for Ischemic Heart Disease

  This study tests whether an outpatient cardiac telerehabilitation program can be as safe and effective as conventional rehab for people with ischemic heart disease.

  Recruiting Lithuanian University of Health Sciences · Kulautuva · NCT07927829

• See if stopping long-term aspirin is as good as continuing it in older adults with stable ischemic heart disease

  In adults 65 and older with stable ischemic heart disease, this trial tests whether stopping daily low-dose aspirin is not worse than continuing it.

  Recruiting at 2 sites Phase 4 Odense University Hospital · Copenhagen and 1 other locations · NCT07795398

• 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

• LONG NAGOMI PMCF: follow-up of the Ultimaster Nagomi stent in long coronary artery lesions

  This project tests the Ultimaster Nagomi drug-eluting stent in adults undergoing PCI for long coronary lesions to collect real-world safety and effectiveness data.

  Recruiting at 10 sites Fundación EPIC · Cabueñes and 9 other locations · NCT07399002

• Endocardial delivery of stem-cell derived heart cells to help severe heart failure

  This study tests endocardial delivery of HS-001 cell sheets made from iPSC-derived cardiomyocytes in adults with severe heart failure and reduced ejection fraction to see if it is safe and may improve heart function over 26 weeks.

  Recruiting at 5 sites Phase 1/2 Heartseed Inc. · Tsukuba, Ibaraki and 4 other locations · NCT07347197

• Deep learning to analyze and track echocardiograms

  This project will test AI tools that help clinicians read echocardiograms and flag adults who may have genetic cardiomyopathy, ischemic heart disease, or cardiac amyloidosis to see if interpretation improves and diagnoses happen faster.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07308704

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.