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

N/ARecruitingNCT03392415

Leif Thuesen2,000 enrolled

Overview

Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,000

Conditions

Chronic Total Occlusion of Coronary Artery Heart Failure Angina Pectoris

Interventions

CTO PCIPROCEDURE

attempted percutaneous coronary intervention of the chronic total coronary occlusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Outcomes

Primary Outcomes

All-cause mortality

All-cause mortality after inclusion of 2000 patients

Time frame: a minimal follow-up of 6 months

Quality of life assessment

Quality of life assessment by 12-Item Short Form Survey Instrument (SF-12v2)

Time frame: 6 months.

Secondary Outcomes

MR perfusion

Reduction of inducible myocardial perfusion defect evaluated, improvement of left ventricular function and correlation of angina and perfusion defect

Time frame: 6 months

Echocardiography

evaluation of systolic and diastolic left ventricular function compared to index echocardiography before CTO PCI.

Time frame: 6 months

Central Contacts

Martin K Christensen, MD

CONTACT

+45 9766 4454 m.kirk@rn.dk

Leif Thuesen, MD

CONTACT

+45 9766 4465 leif.thuesen@rn.dk

Data from ClinicalTrials.gov

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