The NOrdic-Baltic Randomized Registry Study for Evaluation of PCI in Chronic Total Coronary Occlusion

Launched by LEIF THUESEN · Jan 2, 2018

Keywords

ClinConnect Summary

This clinical trial, called the Nordic-Baltic Randomized Registry Study, is looking at a specific treatment for patients with a condition known as Chronic Total Occlusion (CTO) of the coronary arteries. This means that one or more blood vessels that supply the heart are completely blocked. The study aims to see how well a procedure called Percutaneous Coronary Intervention (PCI), which helps open these blocked vessels, works when combined with the best possible medical treatment. The trial is currently recruiting participants aged 65 to 74, and both men and women can join if they have at least one CTO lesion that can be treated with PCI and are experiencing symptoms like chest pain or shortness of breath.

To participate, individuals must have stable heart disease and specific signs that indicate their heart is not getting enough blood. However, certain people are not eligible, such as those with severe kidney problems, certain recent treatments for other heart issues, or those who might not survive for more than a year. If someone joins the study, they can expect to receive either the PCI procedure or continue with their current medical treatment. The goal is to gather important information that can help improve treatment for heart conditions in the future.

Gender

ALL

Eligibility 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