Evaluating PCI for Chronic Total Coronary Occlusion
The NOrdic-Baltic Randomized Registry Study for Long-term Clinical Evaluation of Adjunction of PCI to Optimal Medical Therapy in Chronic Total Coronary Occlusion
This study tests whether a procedure called PCI can help people with blocked heart arteries feel better when combined with the best medical treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg) |
| Trial ID | NCT03392415 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of percutaneous coronary intervention (PCI) in patients with chronic total occlusion (CTO) of coronary arteries, in conjunction with optimal medical therapy. It involves a randomized registry approach to assess outcomes in patients who have stable coronary artery disease and specific symptoms or indications of reversible ischemia. Participants will be monitored for improvements in their condition following the intervention.
Who should consider this trial
Good fit: Ideal candidates are patients with at least one CTO lesion that can be treated with PCI and who exhibit symptoms of coronary artery disease.
Not a fit: Patients with a life expectancy of less than one year or those with renal failure on dialysis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from chronic total occlusion and related heart conditions.
How similar studies have performed: Other studies have shown promising results with PCI for chronic total occlusion, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥1 CTO lesion amenable to PCI. * Stable and stabilized coronary artery disease * Symptoms (angina pectoris or shortness of breath) and/or signs of reversible perfusion defect by SPECT, PET or MR and/or angiographic/echocardiographic indication of reversible ischemia. * CTO lesion in a major coronary vessel supplying a significant myocardial territory (vessel diameter usually ≥3mm). Exclusion Criteria: * Expected survival \<1 year. * Renal failure on dialysis. * Stable non-CTO lesions treated within one month. * Declined informed consent. * Regarding CMR: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants
Where this trial is running
Aalborg
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
Study contacts
- Study coordinator: Martin K Christensen, MD
- Email: m.kirk@rn.dk
- Phone: +45 9766 4454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.