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

Study Overview
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Brief Summary
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Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.

Official Title
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The NOrdic-Baltic Randomized Registry Study for Long-term Clinical Evaluation of Adjunction of PCI to Optimal Medical Therapy in Chronic Total Coronary Occlusion

Conditions
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Chronic Total Occlusion of Coronary Artery, Heart Failure, Angina Pectoris

Intervention / Treatment
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* Procedure: CTO PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized registry with option of crossover after 6months
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Initial conservative treatment<br>Optimal medical therapy and option for crossover after 6 months or fulfillment of certain conditions | Procedure: CTO PCI<br>* attempted percutaneous coronary intervention of the chronic total coronary occlusion<br>|
| Experimental: initial interventional treatment<br>CTO PCI attempt as initial strategy with medical optimization simultaneously | Procedure: CTO PCI<br>* attempted percutaneous coronary intervention of the chronic total coronary occlusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality after inclusion of 2000 patients | a minimal follow-up of 6 months | 
| Quality of life assessment | Quality of life assessment by 12-Item Short Form Survey Instrument (SF-12v2) | 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MR perfusion | Reduction of inducible myocardial perfusion defect evaluated, improvement of left ventricular function and correlation of angina and perfusion defect | 6 months | 
| Echocardiography | evaluation of systolic and diastolic left ventricular function compared to index echocardiography before CTO PCI. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic total occlusion, CTO, PCI, percutaneus coronary intervention