Dissolving stent could change heart disease treatment
NCT ID NCT05540223
First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times
Summary
This study compares a new type of heart stent called Freesolve, which is made of magnesium and dissolves over time, to a standard permanent metal stent. About 1,859 people with coronary artery disease will receive one of the two stents. The goal is to see if the dissolving stent is as safe and effective at keeping arteries open after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Freesolve RMS (a dissolving heart stent that releases a drug to prevent re-narrowing)
- What this could lead to
- If successful, this could offer a safer alternative to permanent metal stents, as the scaffold dissolves over time, potentially reducing long-term complications.
- What could go wrong
- This is a large but still early-stage comparison; the dissolving stent may not perform as well as the standard stent, and there is a risk of heart attack, need for repeat procedures, or other serious events.
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
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1,861 people
The number who actually took part.
- Started
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May 2024
- Expected to finish
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Feb 2032
An estimate. End dates often move.
- 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
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18 to 80 years
- Sex
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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.
Clinical Inclusion Criteria: 1. Subject is ≥ 18 years and ≤ 80 years of age 2. Subject has provided written informed consent as approved by the Independent Ethical Committee (IEC) or Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures 3. Subject is eligible for PCI according to the applicable guidelines 4. Subject is an acceptable candidate for coronary artery bypass surgery 5. Subjects with stable or unstable angina pectoris, documented silent ischemia/abnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion Note: STEMI patients may be eligible for the study for treatment of selected non-culprit lesions, if: * Subject and target lesion(s) meet all inclusion and no exclusion criteria and consent occurs at least ≥ 72 hours after successful treatment of the culprit lesion(s) \[lesion(s) causing the acute STEMI\]; * Subject is hemodynamically stable with documented declining cardiac biomarkers; * Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s) 6. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine 7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization) 8. Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study Angiographic Inclusion Criteria: 1. Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries 2. Target vessel must have a reference diameter between 2.5-4.2 mm by visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT) 3. Target lesion must be ≤28mm in length by operator visual estimation, which may be assissted by QCA / IVUS / OCT, (or \< 20 mm for target lesion(s) to be treated with a study device \< 3.0 mm in diameter) and should be amenable to treatment with a single study device 4. Target lesion stenosis ≥ 50% and \< 100% by operator visual estimation, which may be assisted by QCA / IVUS / OCT. Target lesion stenosis \< 70% by visual estimation, should have clinical justification for treatment as per local standards. 5. Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1 Clinical Exclusion Criteria: 1. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study 2. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with STEMI \< 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment. 3. Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure or prior PCI within a non-target vessel \<72 hours prior to the index procedure if successful and uncomplicated 4. Subject is on dialysis or with impaired renal function (serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 72 hours prior to the index procedure) 5. Subject has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin, sirolimus, everolimus (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminium, tantalum), or Xience stent material (cobalt, chromium, tungsten, nickel, -methacrylic polymer, and fluoropolymer) 6. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted) 7. Life expectancy less than 1 year 8. Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained 9. In the investigator's opinion subject will not be able to comply with the follow-up requirements 10. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained for a minimum of 1 month 11. Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure 12. Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT 13. Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug Angiographic Exclusion Criteria: 1. Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion 2. Left main coronary artery disease 3. Target lesion was totally occluded (100% stenosis) 4. Thrombus in target vessel 5. Future planned staged PCI either in target or non-target vessel 6. Ostial target lesion within the left descending (LAD), left circumflex (LCx), or right coronary artery (within 5.0 mm of vessel origin) 7. Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation 8. Target lesion is located in or supplied by an arterial or venous bypass graft 9. Target lesion with excessive tortuosity proximal to or within the lesion based on visual estimation or heavily calcified target lesion which cannot be adequately pre-dilated by a non-compliant and/or cutting/scoring balloon as described in angiographic exclusion criteria 10. 10. The target lesion requires treatment with the device other than the non-compliant balloon and/or cutting/scoring balloon prior to scaffold/stent placement (including but not limited to atherectomy devices, intravascular lithotripsy, drug-coated balloons etc.) 11. Target vessel was treated with brachytherapy any time prior to the index procedure. 12. Unsuccessful pre-dilatation, defined as residual stenosis \> 20% (by visual estimation) and / or angiographic complications (e.g. distal embolization, side branch closure, flow-limiting dissections)
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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.
Contacts and locations
Locations
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Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss
Neuss, 41464, Germany
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