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Tests treatment safety and results for Coronary Disease
Official title Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions
ClinicalTrials.gov ID: NCT07258290
What this study is testing
- What it's testing
- The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Clinical
- Subject is ≥ 18 years and ≤ 80 years of age
- Subject has provided written informed consent as approved by the Ethics Committee / Institutional Review Board (IRB) of the respective clinical site...
- Subject is eligible for PCI according to the applicable guidelines
- Subject is an acceptable candidate for coronary artery bypass surgery
You likely can't join if
- 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)
- Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine
- Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)
- Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study Angiographic...
See the full eligibility criteria
Who can join
- Clinical
- Subject is ≥ 18 years and ≤ 80 years of age
- 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
- Subject is eligible for PCI according to the applicable guidelines
- Subject is an acceptable candidate for coronary artery bypass surgery
- people 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...
- Subject and target lesion(s) meet all inclusion and no
What rules you out
- 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)
- Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine
- Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)
- Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study Angiographic Inclusion Criteria:
- people with a maximum of two single de novo target lesions each in separate native coronary arteries
- 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...
- 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...
- 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...
- Target lesion must have a Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 1 Clinical Exclusion Criteria:
- Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
- 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) people are eligible for study enrollment
- 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
- 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)
- 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)...
- 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...
- Life expectancy less than 1 year
- Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained
- In the investigator's opinion subject will not be able to comply with the follow-up requirements
- people 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
- Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure
- Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT
- Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug
- Subject has known severe aortic or mitral valve stenosis/insufficiency or has previously undergone transcatheter aortic valve replacement (TAVR) Angiographic Exclusion Criteria:
- Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion
- Left main coronary artery disease
- Target lesion is totally occluded (100% stenosis)
- Thrombus in target vessel
- Future planned staged PCI either in target or non-target vessel
- Ostial target lesion within the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA) (within 5.0 mm of vessel origin)
- Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation
- Target lesion is located in or supplied by an arterial or venous bypass graft
- 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...
- 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...
- Target vessel was treated with brachytherapy any time prior to the index procedure.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.