BIOTRONIKS * Acute performance Of a Drug Eluting Absorbable Metal Scaffold (DREAMS 2G) in patients with de Novo Lesions in NatiVE Coronary Arteries: BIOSOLVE-III
- Conditions
- coronary stenosisnarrowing of the vessels (arteries) which supply the heart with blood10011082
- Registration Number
- NL-OMON42722
- Lead Sponsor
- Biotronik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1.Subject is > 18 years and < 80 years of age
2.Written subject informed consent available prior to PCI
3.Subject 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.Subject with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
7.Reference vessel diameter between 2.7-3.8 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: > 50% - < 100%
10.Eligible for Dual Anti Platelet Therapy (DAPT)
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.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.Subject is on dialysis
10.Planned intervention of the target vessel 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 prior to scaffold placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
17.Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of DREAMS 2G 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, Everolimus or similar drugs (i.e., ABT 578, Biolimus, Tacrolimus), PLLA, Silicon Carbide, Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum
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 (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 imped 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.Subject with tortuous vessel that may impair scaffold placement in the region of obstruction or proximal to the lesion
25.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>The primary endpoint of this study is acute performance of the DREAMS 2G<br /><br>assessed by Procedure Success.<br /><br>Procedure Success is defined as achievement of a final diameter stenosis of<br /><br><30% by QCA (using any percutaneous method) without the occurrence of death,<br /><br>Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion<br /><br>during the hospital stay.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Clinical endpoints:<br /><br>* Target Lesion Failure (TLF*) at 1, 6 12, 24 and 36-months post procedure.<br /><br>* Scaffold thrombosis rate at 1,6, 12, 24 and 36-months (according to ARC<br /><br>definition)<br /><br><br /><br>* TLF is a composite of cardiac death, target vessel Q-wave or non-Q wave<br /><br>Myocardial Infarction (MI)**, Coronary Artery Bypass Grafting (CABG),<br /><br>clinically driven TLR.<br /><br><br /><br>**Myocardial infarction will be adjudicated according to the Society for<br /><br>Cardiovascular Angiography and Interventions (SCAI) for a definition of<br /><br>Clinically Relevant Myocardial Infarction After Coronary Revascularization (for<br /><br>peri-procedural MIs)<br /><br><br /><br><br /><br>Angiographic endpoints:<br /><br>* Binary in-scaffold and in-segment restenosis rate at 12-months<br /><br>* % in-scaffold and in-segment diameter stenosis at 12-months<br /><br>* In-segment Late lumen loss at 12-months<br /><br>* In-scaffold Late lumen loss at 12-months</p><br>