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

August 4, 2026 updated by: Leif Thuesen

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: a minimal follow-up of 6 months
All-cause mortality after inclusion of 2000 patients
a minimal follow-up of 6 months
Quality of life assessment
Time Frame: 6 months.
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
Time Frame: 6 months
Reduction of inducible myocardial perfusion defect evaluated, improvement of left ventricular function and correlation of angina and perfusion defect
6 months
Echocardiography
Time Frame: 6 months
evaluation of systolic and diastolic left ventricular function compared to index echocardiography before CTO PCI.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-economic
Time Frame: 1 year
Socio-economic consequenses of CTO PCI. Treatment cost compared to coronary bypass surgery
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leif Thuesen

Investigators

  • Study Chair: Søren Pihlkjær Hjortshøj, MD, Aalborg University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

October 1, 2025

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20170063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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