NL-OMON46947
Recruiting
Not Applicable
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 - BIOSOLVE-II
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- coronary stenosis
- Sponsor
- Biotronik
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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