BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries: BIOSOLVE-II

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Subject is >= 18 years and <= 80 years of age
2. Written subject informed consent available prior to PCI
3. Subjects with stable or unstable angina pectoris or documented silent ischemia
4. Subject eligible for PCI
5. Subject acceptable candidate for coronary artery bypass surgery
6. Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
7. Reference vessel diameter between 2.2-3.8 mm by visual estimation, depending on the scaffold size used.
8. Target lesion length <= 21 mm by visual estimation, depending on the scaffold size used.
9. Target lesion stenosis by visual estimation, assisted by QCA / IVUS: >= 50% - < 100%
10. Eligible for Dual Anti Platelet Therapy (DAPT)

Exclusion Criteria

1. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
2. Evidence of myocardial infarction within 72 hours prior to index procedure
3. Subjects with a >=2 fold CK level or in absence of CK a >=3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
4. Unprotected left main coronary artery disease
5. Three-vessel coronary artery disease at time of procedure
6. Thrombus in target vessel
7. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
8. Planned interventional treatment of any non-target vessel within 30 days post-procedure
9. Subjects on dialysis
10. Planned intervention of the target vessel within 6-month after the index procedure
11. Ostial target lesion (within 5.0 mm of vessel origin)
12. Target lesion involves a side branch >2.0 mm in diameter
13. Documented left ventricular ejection fraction (LVEF) <= 30%
14. Heavily calcified lesion
15. Target lesion is located in or supplied by an arterial or venous bypass graft
16. The target lesion requires treatment with a device other than the pre-dilatation balloon or cutting/scoring balloon prior to scaffold placement (including but not limited to rotational atherectomy, etc.)
17.Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of DREAMS and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections that can*t be covered by a single scaffold), by visual estimation
18. Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
19. Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
20. Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
21. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
22. Life expectancy less than 1 year
23. Planned surgery or dental surgical procedure within 6 months after index procedure
24. In the investigators opinion subjects will not be able to comply with the follow-up requirements

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint will be in-segment late lumen loss (LLL) at 6-month<br /><br>post-procedure. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical<br /><br>• Target Lesion Failure (TLF; composite of Cardiac Death, Target Vessel Q-wave<br /><br>or non-Q wave Myocardial Infarction (MI), Coronary Artery Bypass Grafting<br /><br>(CABG), clinically driven Target Lesion Revascularization (TLR)) at 1, 6, 12,<br /><br>24, 36 and 60-month<br /><br>• Scaffold thrombosis rate at 1, 6, 12, 24, 36 and 60-month (according to ARC<br /><br>definition)<br /><br>• Procedure success and device Success<br /><br><br /><br>Angiographic<br /><br>• Binary in-scaffold and in-segment restenosis rate at 6, 12 and 36-month<br /><br>• % in-scaffold and in-segment diameter stenosis at 6, 12 and 36-month<br /><br>• Late lumen loss in-scaffold at 6, 12 and 36-month and in-segment at 12 and<br /><br>36-month<br /><br><br /><br>OCT and IVUS<br /><br>• Descriptive analysis of vessel morphology, lesion composition and scaffold<br /><br>strut data<br /><br><br /><br>Vasomotion<br /><br>• Descriptive analysis of vessel movement</p><br>