Opening blocked heart arteries may beat drugs alone for reducing oxygen starvation

NCT ID NCT03756870

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial tests whether opening a chronically blocked heart artery with a stent (PCI) reduces heart muscle starvation more than medication alone. It includes 48 patients with a total blockage who have significant ischemia on imaging. The study measures changes in ischemia, chest pain, and heart function over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
percutaneous coronary intervention (PCI) with a drug-eluting stent
What this could lead to
If PCI reduces ischemia more than medication alone, it could improve heart function and reduce chest pain in patients with blocked arteries.
What could go wrong
This is a small, early-phase trial with only 48 participants, so results may not apply broadly. PCI carries risks like bleeding, infection, or artery damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2019

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Patient has a clinical indication to perform CTO PCI. 3. 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. The ischemic threshold is defined as: * \>12.5% of ischemia; * With \<50% transmural extent of infarction. 4. Subject agrees to undergo follow-up SPECT-CT at 6 months after initial inclusion 5. 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. Exclusion Criteria: * 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; * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam UMC, location AMC

    RECRUITING

    Amsterdam, 1105AZ, Netherlands

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