Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System

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 EthicalCommittee (IEC) or Institutional Review Board (IRB) of the respective clinical siteprior 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 silentischemia/abnormal physiologic testing or hemodynamically stable non-ST elevationmyocardial infarction (NSTEMI) patients without angiographic evidence of thrombus attarget lesion Note: STEMI patients may be eligible for the study for treatment of selectednon-culprit lesions, if:

• Subject and target lesion(s) meet all inclusion and no exclusion criteria andconsent occurs at least ≥ 72 hours after successful treatment of the culpritlesion(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 arenot culprit lesion(s)

6. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus eitherclopidogrel, prasugrel, ticagrelor or ticlopidine

7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior toor during the procedure (prior to randomization)

8. Subject is willing and able to comply with protocol requirements, includingcompletion 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 nativecoronary arteries

2. Target vessel must have a reference diameter between 2.5-4.2 mm by visualestimation, 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 beassissted by QCA / IVUS / OCT, (or < 20 mm for target lesion(s) to be treated with astudy device < 3.0 mm in diameter) and should be amenable to treatment with a singlestudy device

4. Target lesion stenosis ≥ 50% and < 100% by operator visual estimation, which may beassisted 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 theduration of the study

2. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent withSTEMI < 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for studyenrollment.

3. Subject has undergone prior PCI within the target vessel during the last 12 monthsprior to the index procedure or prior PCI within a non-target vessel <72 hours priorto the index procedure if successful and uncomplicated

4. Subject is on dialysis or with impaired renal function (serum creatinine > 2.5 mg/dLor 221 µmol/L, determined within 72 hours prior to the index procedure)

5. Subject has a known allergy to contrast medium that cannot be adequatelypremedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin andbivalirudin, sirolimus, everolimus (or similar limus drugs), poly L-lactide, thescaffold 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 steroidsare permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitusis 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-uprequirements

10. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unlessDAPT + 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 tothe index procedure

12. Subject with active bleeding disorder, active coagulopathy, or any other reason, whois ineligible for DAPT

13. Subject is currently participating or plans to participate in another study with aninvestigational device or an investigational drug

Angiographic Exclusion Criteria:

1. Target vessel has been previously treated and the target lesion is within 5 mmproximal 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), orright 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-devicestrategy 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 onvisual estimation or heavily calcified target lesion which cannot be adequatelypre-dilated by a non-compliant and/or cutting/scoring balloon as described inangiographic exclusion criteria 10.

10. The target lesion requires treatment with the device other than the non-compliantballoon and/or cutting/scoring balloon prior to scaffold/stent placement (includingbut not limited to atherectomy devices, intravascular lithotripsy, drug-coatedballoons 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 visualestimation) and / or angiographic complications (e.g. distal embolization, sidebranch closure, flow-limiting dissections)