The NOrdic-Baltic Randomized Registry Study for Evaluation of PCI in 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03392415

Acronym

NOBLE-CTO

Enrollment

2000

Registered

2018-01-08

Start date

2018-06-01

Completion date

2028-07-01

Last updated

2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

chronic total occlusion, CTO, PCI, percutaneus coronary intervention

Brief summary

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

Interventions

PROCEDURECTO PCI

attempted percutaneous coronary intervention of the chronic total coronary occlusion

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized registry with option of crossover after 6months

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Contacts

STUDY_CHAIRSøren Pihlkjær Hjortshøj, MD

Aalborg University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026