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

Leif Thuesen

Status: Enrolling

Conditions: Angina Pectoris; Heart Failure; Chronic Total Occlusion of Coronary Artery

Treatments: Procedure: CTO PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT03392415

N-20170063

Details and patient eligibility

About

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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Initial conservative treatment

Active Comparator group

Description:

Optimal medical therapy and option for crossover after 6 months or fulfillment of certain conditions

Treatment:

Procedure: CTO PCI

initial interventional treatment

Experimental group

Description:

CTO PCI attempt as initial strategy with medical optimization simultaneously

Treatment:

Procedure: CTO PCI