Chronic Total Occlusion of Coronary ArteryREVISE-CTONCT03756870
Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction
A study testing Percutaneous coronary intervention (PCI) in people with Chronic Total Occlusion of Coronary Artery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Randomized trials could not yet establish favourable outcomes of CTO PCI on hard endpoints such as ejection fraction or mortality, when compared 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
- What is being tested?
- Percutaneous coronary intervention (PCI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2019to 1 Jan 2030
- 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
- A chronic total occlusion is present and target lesion. A CTO is required to meet the following characteristics:
- A 100% luminal narrowing of the coronary artery without antegrade flow, i.e. Thrombolysis in Myocardial Infarction flow grade 0 or 1;
- Older than 3 months, established with previous PCI or with angiographic characteristics;
- Amenable to percutaneous revascularization.
- Patient has a clinical indication to perform CTO PCI.
- A SPECT is performed at baseline to assess ischemia and a cardiac magnetic resonance imaging (CMR) scan to assess viability, as part of routine patient care. Patients are deemed eligible for the randomized trial when they meet the ischemic threshold in the CTO territory.
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- The ischemic threshold is defined as:
- >12.5% of ischemia;
- With <50% transmural extent of infarction.
- Subject agrees to undergo follow-up SPECT-CT at 6 months after initial inclusion
- Subject is able to verbally confirm understanding and he/she provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
Who cannot join
- Subject is younger than 18 years of age;
- Persistent or permanent atrial fibrillation;
- Presence of a non-MRI compatible cardiac device, i.e. pacemaker or implantable cardioverter defibrillator;
- Body weight > 250 kg;
- Unable to exert, i.e. due to physical disability;
- Any contraindication for SPECT or CMR, i.e. cerebrovascular clips, claustrophobia;
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- Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] <60 mL/min/1.73m2 or serum creatinine level of >2.5 mg/dL or subject on dialysis);
- Hypersensitivity or allergy to contrast with inability to properly pre-hydrate;
- Presence of a comorbid condition with a life expectancy of less than one year;
- Participation in another trial;
- Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, 1105AZ
Anna van Veelen, MD
About this study
Official title: REvascularization Versus Optimal Medical Therapy on Left Ventricular ISchemia Reduction: Exploring the Associations Between Ischemia, Functional Outcome and Collaterals in the Treatment of Chronic Total Occlusion Patients
Rationale: Randomized trials could not yet establish favourable outcomes of CTO PCI on hard endpoints such as ejection fraction or mortality, when compared to optimal medical therapy. However, patients after CTO PCI appeared to be more frequently free of angina complaints, but the aetiology behind this is not fully understood. The investigators hypothesize that PCI of the CTO in patients preselected with an ischemic threshold (>12.5%) on cardiac imaging leads to a reduction of the ischemic burden and therefore an increased benefit on functional outcomes.
Objective: Primary objective is to determine whether PCI of the CTO will yield a higher reduction of ischemia assessed by exercise myocardial perfusion SPECT-CT from baseline to 6-month follow-up compared to a control group. Secondary objectives are 1) to evaluate the effect of PCI of the CTO on improvement in functional status, infarct size and left ventricular function from baseline to follow-up compared to the control group; 2) to study the association between ischemia reduction and functional outcome and left ventricular function; 3) to assess the influence of the collateral flow index on the ischemic burden (reduction), functional status, infarct size and left ventricular (contractile) function (hibernation).
Read more
Study design: open multicentre randomized trial
Study population: 2x24 patients eligible for CTO PCI
Intervention: CTO PCI
Primary endpoint: ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.
- Being tested
- Percutaneous coronary intervention (PCI)
- Keywords
- Chronic total coronary occlusion, Percutaneous coronary intervention, Optimal medical therapy, Myocardial ischemia
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Procedure or surgery
A percutaneous coronary intervention of the chronic total occlusion with a drug-eluting stent.
| Study group | Role | What they receive |
|---|---|---|
| CTO PCI | Experimental | Patients will receive optimal medical therapy, with percutaneous coronary intervention of the chronic total occlusion. Receives: Procedure: Percutaneous coronary intervention (PCI) |
| OMT | No intervention | Patients will receive optimal medical therapy, without percutaneous coronary intervention of the chronic total occlusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemia
Ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.
Measured: 6 months follow-up
Secondary outcomes (3)
Change in angina status assessed with the Seattle Angina Questionnaire.
5 Seattle Angina Questionnaire subscales (0-100), higher scores indicating better angina status.
Measured: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Quality of life assessed with the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
MLHFQ scale (0-105), lower scores indicating better quality of life.
Measured: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
The left ventricular ejection fraction assessed with cardiac magnetic resonance imaging
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 posted28 Nov 2018
- Study start1 Jul 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- 1:1 parallel design
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.P.S Henriques, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756870
- Sponsor's protocol ID
- REVISE-CTO
- Acronym
- REVISE-CTO
- Status last verified
- Jul 2026
- First submitted
- 26 Nov 2018
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REvascularization Versus Optimal Medical Therapy on Left Ventricular ISchemia Reduction: Exploring the Associations Between Ischemia, Functional Outcome and Collaterals in the Treatment of Chronic Total Occlusion Patients
- ClinicalTrials.gov ID
- NCT03756870
- Acronym / sponsor ID
- REVISE-CTO / REVISE-CTO
- Keywords
- Chronic total coronary occlusion, Percutaneous coronary intervention, Optimal medical therapy, Myocardial ischemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 28 Nov 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.
Rationale: Randomized trials could not yet establish favourable outcomes of CTO PCI on hard endpoints such as ejection fraction or mortality, when compared to optimal medical therapy. However, patients after CTO PCI appeared to be more frequently free of angina complaints, but the aetiology behind this is not fully understood. The investigators hypothesize that PCI of the CTO in patients preselected with an ischemic threshold (>12.5%) on cardiac imaging leads to a reduction of the ischemic burden and therefore an increased benefit on functional outcomes.
Objective: Primary objective is to determine whether PCI of the CTO will yield a higher reduction of ischemia assessed by exercise myocardial perfusion SPECT-CT from baseline to 6-month follow-up compared to a control group. Secondary objectives are 1) to evaluate the effect of PCI of the CTO on improvement in functional status, infarct size and left ventricular function from baseline to follow-up compared to the control group; 2) to study the association between ischemia reduction and functional outcome and left ventricular function; 3) to assess the influence of the collateral flow index on the ischemic burden (reduction), functional status, infarct size and left ventricular (contractile) function (hibernation).
Study design: open multicentre randomized trial
Study population: 2x24 patients eligible for CTO PCI
Intervention: CTO PCI
Primary endpoint: ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 parallel design
| Arm | Type | Receives |
|---|---|---|
| CTO PCI | Experimental | Procedure: Percutaneous coronary intervention (PCI)Patients will receive optimal medical therapy, with percutaneous coronary intervention of the chronic total occlusion. |
| OMT | No intervention | –Patients will receive optimal medical therapy, without percutaneous coronary intervention of the chronic total occlusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A chronic total occlusion is present and target lesion. A CTO is required to meet the following characteristics:
- Patient has a clinical indication to perform CTO PCI.
- A SPECT is performed at baseline to assess ischemia and a cardiac magnetic resonance imaging (CMR) scan to assess viability, as part of routine patient care. Patients are deemed eligible for the randomized trial when they meet the ischemic threshold in the CTO territory.
- Subject agrees to undergo follow-up SPECT-CT at 6 months after initial inclusion
- Subject is able to verbally confirm understanding and he/she provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
Key exclusion criteria (11 listed)
- Subject is younger than 18 years of age;
- Persistent or permanent atrial fibrillation;
- Presence of a non-MRI compatible cardiac device, i.e. pacemaker or implantable cardioverter defibrillator;
- Body weight > 250 kg;
- Unable to exert, i.e. due to physical disability;
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 |
|---|---|---|
| Percutaneous coronary intervention (PCI)A percutaneous coronary intervention of the chronic total occlusion with a drug-eluting stent. | Procedure or surgery | CTO PCI |
Primary outcome
Ischemia
Time frame: 6 months follow-up
Ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.
3 secondary outcomes
Change in angina status assessed with the Seattle Angina Questionnaire.
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Quality of life assessed with the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
The left ventricular ejection fraction assessed with cardiac magnetic resonance imaging
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 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention (PCI) in people with Chronic Total Occlusion of Coronary Artery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Jul 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 Netherlands. 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?
Contact Prof. J.P.S. Henriques, MD PhD (+31205666405, j.p.henriques@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemia (time frame: 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.