NCT03563417

Brief Summary

Study design Prospective randomized open labeled multicenter study Hypotheses

  • CTO in native coronary artery
  • Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.
  • Age ≥18 yrs.
  • Able to provide written Informed consent and willing to comply with the specified follow-up contacts
  • Target artery ≥ 2.5 mm Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into: Cohort A: Asymptomatic (CCS \< 2 and SAQ QoL \> 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO Cohort C: patients enrolled but not randomized in cohort A or B Exclusion criteria (for both cohort A and B)
  • NSTEMI or STEMI within 1 month
  • Coronary anatomy not suitable for CTO-procedure
  • Coronary artery disease involving the left main/three-vessel disease with indication for CABG following heart team conference
  • Life expectancy \< 2 years
  • Severe chronic pulmonary disease (FEV1 \< 30 % of predicted value)
  • Contraindication to dual anti-platelet therapy
  • Pregnancy
  • eGFR \< 30 mL/min/1.73 m2
  • In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.
  • Severe valvular heart disease Primary endpoint Cohort A: Composite endpoint of MACCE (all-cause mortality, stroke, any myocardial infarction, clinically driven revascularization\*), hospitalization for heart failure or incidence of malignant arrhythmias. \*CCS class ≥ 2 and/or QoL score \< 60. Same criteria used as for allocation to Cohort B Cohort B: SAQ Quality of Life Assessment after 6 months. Number of patients 1,560 (1200 in cohort A/360 in cohort B Follow up time Cohort A: 5 years Cohort B: 6 months

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,560

participants targeted

Target at P75+ for not_applicable

Timeline
79mo left

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
6 countries

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Nov 2018Nov 2032

First Submitted

Initial submission to the registry

June 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 6, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2032

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

10 years

First QC Date

June 10, 2018

Last Update Submit

December 29, 2025

Conditions

Ischemic Heart DiseaseChronic Total Occlusion of Coronary Artery

Outcome Measures

Primary Outcomes (2)

  • Major Adverse Cerebral and Cardiovascular Events

    Primary outcome in the Cohort A.

    5 Year

  • Quality of life - Seattle Angina Questionnaire

    Primary outome in the Cohort B

    6 months

Study Arms (2)

PCI

ACTIVE COMPARATOR
Procedure: Percuteneous Coronary Intervention

OMT

OTHER
Other: Optimal Medical Therapy

Interventions

Optimal Medical TherapyOTHER

Initiation and titration of optimal medical therapy in the control arm.

OMT
Percuteneous Coronary InterventionPROCEDURE

PCI of Chronic Total Occlusions

PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CTO in native coronary artery
  • Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.
  • Age ≥18 yrs.
  • Able to provide written informed consent and willing to comply with the specified follow-up contacts.
  • Target artery ≥ 2.5 mm
  • Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into:
  • Cohort A: Asymptomatic (CCS \< 2 and SAQ QoL \> 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO
  • Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO assess by nuclear imaging.
  • Cohort C: Screening population not eligible for randomization in cohort A or B

You may not qualify if:

  • NSTEMI or STEMI within 1 month
  • Coronary anatomy not suitable for CTO-procedure
  • Coronary disease involving the left main/three vessel disease with indication for CABG following heart team conference.
  • Life expectancy \< 2 years
  • Severe chronic pulmonary disease (FEV1 \< 30 % of predicted value)
  • Contraindication to dual anti-platelet therapy
  • Pregnancy
  • eGFR \< 30 mL/min/1.73 m2
  • In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.
  • Severe valvular heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Gentofte Hospital

Hellerup, 2900, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

North-Estonia Medical Centre

Tallinn, 13419, Estonia

RECRUITING

Helsinki University Central Hospital

Helsinki, 00029, Finland

ACTIVE NOT RECRUITING

Kuopio University Hospital

Kuopio, 70210, Finland

ACTIVE NOT RECRUITING

Heart Hospital Tampere

Tampere, 33520, Finland

RECRUITING

Turku University Hospital

Turku, 20521, Finland

RECRUITING

Clinique Louis Pasteur

Essey-lès-Nancy, 54270, France

ACTIVE NOT RECRUITING

Cardiovascular Institute, Groupe Hospitalier Mutualiste

Grenoble, 38000, France

RECRUITING

Hospital Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

ACTIVE NOT RECRUITING

Hospital Galdakao

Galdakao, Bizkaia, 48960, Spain

RECRUITING

Hospital Vall de Hebron

Barcelona, 08035, Spain

ACTIVE NOT RECRUITING

Hospital Clinic

Barcelona, 08036, Spain

RECRUITING

Hospital de Bellvitge

Barcelona, 08907, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital la Paz

Madrid, 28046, Spain

ACTIVE NOT RECRUITING

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43005, Spain

RECRUITING

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Skaane University Hospital (Lund)

Lund, 22185, Sweden

ACTIVE NOT RECRUITING

Stockholm South Central Hospital (Södersjukhuset)

Stockholm, 11883, Sweden

ACTIVE NOT RECRUITING

Belfast Health and Social Care Trust, Department of Cardiology

Belfast, BT9 7AB, United Kingdom

ACTIVE NOT RECRUITING

University Hospital Bristol

Bristol, BS1 3NU, United Kingdom

ACTIVE NOT RECRUITING

Barts Health NHS

London, SW17 0QT, United Kingdom

ACTIVE NOT RECRUITING

St George's University Hospital

London, SW17 0QT, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (1)

  • 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: 34238552DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Evald Christiansen, MD PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evald Christiansen, MD PhD

CONTACT

+45 78452028evald.christiansen@dadlnet.dk

Emil N Holck, MD

CONTACT

+45 31419472eh@clin.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant MD PhD

Study Record Dates

First Submitted

June 10, 2018

First Posted

June 20, 2018

Study Start

November 6, 2018

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2032

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

ES(8)SE(3)GB(4)DK(5)FI(4)FR(2)