Coronary artery disease Coronary stenosis
Conditions
Interventions
Percutaneous coronary intervention (PCI) with either the Freesolve or the
Xience stent.
Sponsors
BIOTRONIK Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: See CIP section 7.12. 1. Subject is >=18 years and = 72 hours after successful treatment of the culprit lesion causing 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 elegible for DAPT therapy for at least 6-months. 7. Documented left ventricular ejection fraction (LVEF) >= 30% within 6 months prior to or during the procedure. 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 vessel diameter between 2.5-4.2mm by visual estimation (may be assisted by QCA, IVUS or OCT). 3. Target lesion must be = 50% and = 50% and =1.
Exclusion criteria
Exclusion criteria: See CIP section 7.13 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 2.5 mg/dl or 221 µmol/L, determined within 72 hours prior to the index procedure). 5. known allergy to contrast medium, aspirin, P2Y12 inhibitors, heparin, bivalirudin, sirolimus, everolimus, poly L-lactide, the scaffold 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 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 disorders, 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. 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 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), or right 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-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. The target lesion requires treatment with the 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF) at 12 months, a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, and clinically driven Target Lesion Revascularization (TLR). see also CIP section 7.7 | — |
Secondary
| Measure | Time frame |
|---|---|
| * Safety Objective: Cardiac death at 1, 6, 12, 24, 36, 48 and 60 months; target vessel MI (TV-MI) at 6, 12, 24, 36, 48 and 60 months; definite/probable scaffold thrombosis at 1, 6, 12, 24, 36, 48 and 60 months; *Performance Objective: clinically driven TLR at 1, 6, 12, 24, 36, 48 and 60 months; procedure success. * A powered secondary endpoint analysis in the diabetic population will be performed to support a diabetic indication for Freesolve. * A powered secondary endpoint analysis evaluating cumulative TLF rates between 1- and 5-years post-procedure will be performed. * TLF, composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, and clinically driven TLR at 1, 6, 12, 24, 36, 48 and 60 months. * TVF, a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, and clinically driven Target Vessel Revascularization (TVR) at 1, 6, 12, 24, 36, 48 and 60 months. * Cardiac death at 1, 6, 12, 24, 36, 48 and 60 months. * Cardiovascular death at 1, 6, 12, 24, 36, 48 and 60 months. * All-cause mortality at 1, 6, 12, 24, 36, 48 and 60 months. * Target vessel MI in accordance to protocol defined peri-procedural MI and 3rd universal definitions for non-periprocedural MI at 1, 6, 12, 24, 36, 48 and 60 months. * Any MI (including non-target vessel territory) at 1, 6, 12, 24, 36, 48 and 60 months. * Clinically driven TLR at 1, 6, 12, 24, 36, 48 and 60 months. * Clinically driven TVR at 1, 6, 12, 24, 36, 48 and 60 months. * Definite or probable scaffold thrombosis rate at 1, 6, 12, 24, 36, 48 and 60 months (according to ARC-2 definition). * Procedure success defined as achievement of | — |
Countries
Netherlands
Outcome results
None listed