Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions

Prior treatment

• 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 (time window is defined as the time from the end of previous intervention to the start of index procedure)
• 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)
• Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained.
• 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 is currently participating or plans to participate in another study with an investigational device or an investigational drug
  • 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.
• The target lesion requires treatment with the device other than the non-compliant balloon and/or cutting/scoring balloon prior to scaffold 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.

Other illness

• Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT.
• Left main coronary artery disease

Lab values

• 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)
• 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 (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminum, tantalum)

Other

• Clinical Exclusion Criteria
• Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
• Life expectancy less than 1 year
• In the investigator's opinion subject will not be able to comply with the follow-up requirements
• Target lesion was 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 descending (LAD), left circumflex (LCx), or right coronary artery (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.
• 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)

• Clinical Inclusion Criteria
• Subject is ≥ 18 years and ≤ 80 years of age
• 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
• 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, cangrelor or ticlopidine
• Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to enrollment)
• 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 2.7-4.2 mm by visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT)
• Target lesion must be \>28 mm and ≤ 38 mm in length by operator visual estimation, which may be assisted by QCA / IVUS / OCT, and should 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