Zawał serca: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (26)

1. Clinical Exclusion Criteria
2. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
3. 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.
4. 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)
5. 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)
6. 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)
7. 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)
8. Life expectancy less than 1 year
9. Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained.
10. In the investigator's opinion subject will not be able to comply with the follow-up requirements
11. 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
12. Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure .
13. Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT.
14. Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug Angiographic Exclusion Criteria:
15. Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion.
16. Left main coronary artery disease
17. Target lesion was totally occluded (100% stenosis)
18. Thrombus in target vessel
19. Future planned staged PCI either in target or non-target vessel
20. Ostial target lesion within the left descending (LAD), left circumflex (LCx), or right coronary artery (within 5.0 mm of vessel origin)
21. Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.
22. Target lesion is located in or supplied by an arterial or venous bypass graft.
23. 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.
24. 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.)
25. Target vessel was treated with brachytherapy any time prior to the index procedure.
26. 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)