Opening blocked heart arteries may beat drugs alone for reducing oxygen starvation
NCT ID NCT03756870
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
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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
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2019
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Amsterdam UMC, location AMC
RECRUITINGAmsterdam, 1105AZ, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a vibrating wire reopen completely blocked heart arteries?
- Heart artery blockage showdown: which approach wins?
- Heart stent study reveals long-term narrowing risks after complex artery procedure
- Heart attack prevention: does opening a blocked artery save lives?
- New balloon device shows promise in clearing hardened heart blockages