Dissolving heart stent trial pulled before it even started
NCT ID NCT05417893
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to compare a new type of heart stent that slowly dissolves over time (MeRes100) with standard permanent metal stents in people with coronary artery disease. The trial was planned to include about 2,000 participants worldwide, but it was withdrawn before enrolling anyone. Because no patients were treated, we cannot draw any conclusions about the safety or effectiveness of this device.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sirolimus-eluting bioresorbable vascular scaffold
- What this could lead to
- If successful, this could offer a temporary scaffold that dissolves over time, potentially reducing long-term complications compared to permanent metal stents.
- What could go wrong
- The trial was withdrawn before any patients were enrolled, so no data is available. Earlier studies were small, and bioresorbable scaffolds have had mixed results in the past.
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.
- Started
-
Oct 2022
- Finished
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Sep 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 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.
General Inclusion Criteria: 1. Male or female subject ≥18 years of age 2. Subject who has provided written informed consent 3. Subject must agree to undergo all clinical investigations and follow-up visits as per protocol 4. Subject with documented myocardial ischemia (e.g. stable, unstable angina, or silent ischemia) and who are eligible candidates for elective percutaneous coronary intervention (PCI) 5. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure. This includes clinical trials of medications and/or invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed Angiographic Inclusion Criteria: 1. One de novo target lesion or up-to two de novo target lesions in different epicardial vessels: Different epicardial vessels are defined as left anterior descending artery (LAD) and its branches, left circumflex artery (LCX) arteries and its branches, and right coronary arteries (RCA) and its branches. Thus, for example, the subject must not have two target lesions required to be treated at the LAD and its branches at the same time 2. Each target lesion can be fully covered by one scaffold 3. Target lesion with angiographic evidence of ≥70% stenosis (by visual estimation) and ≥50% (by QCA estimation) with TIMI flow of ≥1. If the target lesion is \<70% stenosed, there must be an evidence of ischemia as per ECG or nuclear scan or fractional flow reserve (FFR) 4. Target lesion(s) located in native coronary artery with reference vessel diameter (RVD) of ≥2.75 mm to ≤4.0 mm and length ≤34 mm by QCA or by visual estimation Exclusion Criteria: 1. Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, ticlopidine inclusive), everolimus, sirolimus or its analog or derivative, poly (L-lactide), poly (DL-lactide), cobalt, PLGA \[poly(DL-lactide-co-glycolide)\], chromium, nickel, tungsten, stainless steel, platinum, platinum-chromium alloy, iron, molybdenum, amorphous silicon carbide, acrylic and fluoropolymers or contrast sensitivity that cannot be adequately pre-medicated 2. Any PCI \<6 months prior to the index procedure 3. Previous CABG or PCI in the target vessel(s) 4. Left ventricular ejection fraction (LVEF) \<30% as evaluated by any non-invasive imaging method including but not limited to, echocardiogram, angiography, Magnetic Resonance Imaging (MRI), Multiple-Gated Acquisition (MUGA) scan, radionuclide ventriculography, Positron Emission Tomography (PET) scan, etc. For subjects with stable Coronary Artery Disease (CAD), LVEF may be obtained within 6 months prior to the procedure. For Acute coronary syndrome (ACS) subjects, LVEF must be evaluated during hospitalization or during index procedure but prior to randomization for confirming the subject's eligibility. 5. Concurrent medical condition with less than three years of life expectancy 6. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months of baseline visit 7. Renal insufficiency as estimated by Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2 or dialysis at the time of screening or creatinine level is more than 1.5 mg/dl 8. Subject with cardiac arrhythmia detected at the time of screening 9. Subject is on immunosuppressant therapy and has immunosuppressive or autoimmune disease. 10. Subject with hepatic disorder or chronic liver disease, known aplastic anaemia, platelet count \<100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3 11. Subject with prior brachytherapy of the target lesion or use of brachytherapy for the treated site restenosis 12. Subject has a history of bleeding diathesis or coagulatory disease, refuses blood transfusion, significant gastrointestinal or urinary bleed within the past 12 months 13. Subject who underwent or needs organ transplant 14. Planned PCI for any clinically significant lesion after index procedure 15. Planned surgery within 12 months after index procedure 16. Pregnant or nursing subject and those who plan pregnancy in the period until 5 years following index procedure (Female subject of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and contraception must be used during participation in this trial) 17. Any newly onset acute myocardial infarction within 1 week (\<7days) or, myocardial enzyme has not returned to normal level (clinically non-significant) after myocardial infarction. 18. Subject with significant peripheral vascular disease that precludes safe access to sheath or catheter Angiographic Exclusion Criteria: 1. Target lesion located within 3 mm of the origin of the LAD or LCx 2. Target lesion involving a bifurcation lesion with side branch ≥2 mm in diameter 3. Highly calcified lesions Classification of calcification: moderate calcification - discontinuous dotted high density image; severe calcification - continuous high density image around the whole vessel wall under continuous X ray by multiple positions. 4. Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes: 1. Residual % Diameter Stenosis (DS) is \< 40% (per visual estimation), (≤ 20% is strongly recommended). 2. TIMI Grade-3 flow (per visual estimation). 3. No angiographic complications (e.g., no-reflow, distal embolization, side branch closure). 4. No dissections NHLBI grade D-F. 5. No chest pain lasting \> 5 minutes. 6. No ST depression or elevation lasting \> 5 minutes 5. Total occlusion (TIMI flow 0), prior to wire crossing 6. Excessive tortuosity (≥ two 45° angles), or extreme angulation (≥90°) proximal to or within the target lesion 7. Lesion is located in left main coronary artery 8. Thrombus in the target vessel determined by angiography or OCT 9. Subject with three-vessel disease where all three vessels require intervention 10. Additional lesion in same coronary vessel which requires treatment 11. Evidence of previous revascularization 1. Previous PCI with or without restenosis from previous intervention 2. Arterial or venous graft with or without lesion located within the graft or distal to a diseased arterial or saphenous vein graft Note: Lesions within 3 mm of the origin of the right coronary artery may be treated
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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.
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