Dissolvable magnesium stent could revolutionize heart disease treatment
NCT ID NCT07258290
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 3 times
Summary
This study tests a new device called Freesolve, a temporary magnesium scaffold that props open blocked heart arteries and then dissolves over time. About 1,859 people with up to two new blockages will receive either this scaffold or a standard permanent stent. The goal is to see if the magnesium scaffold is as safe and effective at keeping arteries open and preventing heart attacks or repeat procedures after one year.
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 1,859 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Jun 2033
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
-
18 to 80 years
- 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.
Clinical Inclusion Criteria: 1. Subject is ≥ 18 years and ≤ 80 years of age 2. Subject has provided written informed consent as approved by the Ethics Committee / 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 operator visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT) 3. Target lesion(s) must be ≤ 36 mm in length by operator visual estimation, which may be assisted by QCA / IVUS / OCT, (or \< 20 mm for target lesion(s) to be treated with a study device \< 3.0 mm in diameter) and must 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 4. Subject is on dialysis or has impaired renal function (serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 7 days 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, aluminum, 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 14. Subject has known severe aortic or mitral valve stenosis/insufficiency or has previously undergone transcatheter aortic valve replacement (TAVR) 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 is 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 anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA) (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. Target lesion requires treatment with a 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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute coronary syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
3 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Charleston Area Medical Center
RECRUITINGCharleston, West Virginia, 25304, United States
-
MedStar Washington Hospital Center
RECRUITINGWashington D.C., District of Columbia, 20010, United States
-
Pauls Stradins Clinical University Hospital
RECRUITINGRiga, LV-1002, Latvia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can heart stent patients go home in 6 hours?
- Can a finger sensor reveal whether an epidural is working?
- Could monthly texts and automatic risk scores stop heart attacks before they start?
- Can AI read heart scans to predict the next heart attack?
- Which early signs foretell recovery in childhood encephalitis?
- AI trained to spot dangerous chest pain faces its biggest test yet