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

NCT03392415 | Active Not Recruiting DMC

• 1 other identifier: N-20170063
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

chronic total occlusion; CTO; PCI; percutaneus coronary intervention

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  All-cause mortality after inclusion of 2000 patients

  a minimal follow-up of 6 months

• Quality of life assessment

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

  6 months.

Secondary Outcomes (2)

• MR perfusion

  6 months

• Echocardiography

  6 months

Other Outcomes (1)

• Socio-economic

  1 year

Study Arms (2)

Initial conservative treatment

ACTIVE COMPARATOR

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

Procedure: CTO PCI

initial interventional treatment

EXPERIMENTAL

CTO PCI attempt as initial strategy with medical optimization simultaneously

Procedure: CTO PCI

Interventions

CTO PCI PROCEDURE

attempted percutaneous coronary intervention of the chronic total coronary occlusion

Initial conservative treatment; initial interventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Leif Thuesen: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Related Publications (2)

• Christensen MK, Eftekhari A, Raungaard B, Steigen TK, Kumsaars I, Riahi S, Sogaard P, Thuesen L. Impact of Percutaneous Intervention Compared to Pharmaceutical Therapy on Complex Arrhythmias in Patients With Chronic Total Coronary Occlusion. Rationale and Design of the CTO-ARRHYTHMIA Study. Cardiovasc Revasc Med. 2023 Sep;54:69-72. doi: 10.1016/j.carrev.2023.04.001. Epub 2023 Apr 10.

  PMID: 37117085 DERIVED

• Rinfret S, Sandesara PB. Reducing Ischemia With CTO PCI: Good News, But Questions Remain. JACC Cardiovasc Interv. 2021 Jul 12;14(13):1419-1422. doi: 10.1016/j.jcin.2021.05.028. No abstract available.

  PMID: 34238552 DERIVED

MeSH Terms

Conditions

Heart Failure; Angina Pectoris

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Søren Pihlkjær Hjortshøj, MD

  Aalborg University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior consultant

Model Details: Randomized registry with option of crossover after 6months

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: January 8, 2018
• Study Start: June 1, 2018
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)