Chronic Total Occlusion of Coronary ArteryNOBLE-CTONCT03392415
The NOrdic-Baltic Randomized Registry Study for Evaluation of PCI in Chronic Total Coronary Occlusion
A study testing CTO PCI in people with Chronic Total Occlusion of Coronary Artery and Heart Failure, run by Leif Thuesen at 1 site in Denmark.
Trial summary
Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery, Heart Failure, Angina Pectoris
- What is being tested?
- CTO PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2018to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.
- Being tested
- CTO PCI
- Keywords
- chronic total occlusion, CTO, PCI, percutaneus coronary intervention
- Medical subject headings
- Heart Failure, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO PCIProcedure or surgery
attempted percutaneous coronary intervention of the chronic total coronary occlusion
| Study group | Role | What they receive |
|---|---|---|
| Initial conservative treatment | Active comparator | Optimal medical therapy and option for crossover after 6 months or fulfillment of certain conditions Receives: Procedure: CTO PCI |
| initial interventional treatment | Experimental | CTO PCI attempt as initial strategy with medical optimization simultaneously Receives: Procedure: CTO PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality after inclusion of 2000 patients
Measured: a minimal follow-up of 6 months
Quality of life assessment
Quality of life assessment by 12-Item Short Form Survey Instrument (SF-12v2)
Measured: 6 months.
Secondary outcomes (2)
MR perfusion
Reduction of inducible myocardial perfusion defect evaluated, improvement of left ventricular function and correlation of angina and perfusion defect
Measured: 6 months
Echocardiography
evaluation of systolic and diastolic left ventricular function compared to index echocardiography before CTO PCI.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Jun 2018
- Primary completion1 Oct 2025
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized registry with option of crossover after 6months
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leif Thuesen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leif Thuesen, Aalborg University Hospital
- Investigators
- Søren Pihlkjær Hjortshøj, MD, Study chair, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392415
- Sponsor's protocol ID
- N-20170063
- Acronym
- NOBLE-CTO
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2017
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37117085Rinfret 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.
PubMed 34238552
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03392415
- Acronym / sponsor ID
- NOBLE-CTO / N-20170063
- Keywords
- chronic total occlusion, CTO, PCI, percutaneus coronary intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Leif ThuesenUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized registry with option of crossover after 6months
| Arm | Type | Receives |
|---|---|---|
| Initial conservative treatment | Active comparator | Procedure: CTO PCIOptimal medical therapy and option for crossover after 6 months or fulfillment of certain conditions |
| initial interventional treatment | Experimental | Procedure: CTO PCICTO PCI attempt as initial strategy with medical optimization simultaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTO PCIattempted percutaneous coronary intervention of the chronic total coronary occlusion | Procedure or surgery | Initial conservative treatment, initial interventional treatment |
Primary outcome
All-cause mortality
Time frame: a minimal follow-up of 6 months
All-cause mortality after inclusion of 2000 patients
Quality of life assessment
Time frame: 6 months.
Quality of life assessment by 12-Item Short Form Survey Instrument (SF-12v2)
2 secondary outcomes
MR perfusion
Time frame: 6 months
Echocardiography
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 37117085Christensen 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.
- Derived from this study: PubMed 34238552Rinfret 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Pihlkjær Hjortshøj, MD study chair
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTO PCI in people with Chronic Total Occlusion of Coronary Artery and Heart Failure, run by Leif Thuesen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: a minimal follow-up of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03392415, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.