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NCT Number: NCT03392415

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Total Occlusion of Coronary Artery Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Heart Failure Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital

Aalborg, 9100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTO PCI

Procedure

attempted percutaneous coronary intervention of the chronic total coronary occlusion

Primary outcomes

  1. All-cause mortality

    Time frame: a minimal follow-up of 6 months

    All-cause mortality after inclusion of 2000 patients

  2. Quality of life assessment

    Time frame: 6 months.

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

Secondary outcomes

  1. MR perfusion

    Time frame: 6 months

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

  2. Echocardiography

    Time frame: 6 months

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

Other outcomes

  1. Socio-economic

    Time frame: 1 year

    Socio-economic consequenses of CTO PCI. Treatment cost compared to coronary bypass surgery

Sponsors and collaborators

Lead sponsor

Leif Thuesen

Other

Registry information

Official study title

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

Acronym: NOBLE-CTO

Important dates

Study start
2018
Primary completion
2025
Study completion
2028
First posted
Jan 8, 2018
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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