Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions

Criteria the registry did not label

• Clinical Inclusion Criteria:
• 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
• 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)
• 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:
• Subjects 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 Tomography (OCT)
• 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
• 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.
• 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) subjects 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), poly L-lactide, the scaffold material (magnesium, aluminum, tantalum), or Xience stent material (cobalt, chromium, tungsten, nickel, methacrylic polymer, and fluoropolymer)
• 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)
• 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
• 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
• 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 balloon as described in angiographic exclusion criteria 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.)
• 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)