This trial is active, not recruiting.

Conditions coronary artery disease, coronary artery stenosis
Treatment percutaneous coronary intervention (dreams) stenting
Sponsor Biotronik AG
Start date October 2013
End date October 2015
Trial size 121 participants
Trial identifier NCT01960504, C1209


BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold
percutaneous coronary intervention (dreams) stenting DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold

Primary Outcomes

In segment Late Lumen Loss
time frame: 6 months post index procedure

Secondary Outcomes

Target Lesion Failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularisation (TLR)
time frame: 1, 6, 12, 24 and 36 months
Scaffold thrombosis rate
time frame: 1, 6, 12, 24 and 36 months
In-scaffold and in-segment Binary Restenosis Rate
time frame: 6 and 12 months
In-scaffold and in-segment Percent Diameter Stenosis
time frame: 6 and 12 months
Late Lumen Loss in segment
time frame: 12 months
Late Lumen Loss in scaffold
time frame: 6 and 12 months
Procedure success
time frame: During the hospital stay to a maximum of the first seven days post index procedure
Device success
time frame: Day 0

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Subject is > 18 years and < 80 years of age - Written subject informed consent available prior to PCI - Subjects with stable or unstable angina pectoris or documented silent ischemia - Subject eligible for PCI - Subject acceptable candidate for coronary artery bypass surgery - Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions. - Reference vessel diameter between 2.2-3.8 mm by visual estimation - Target lesion length ≤ 21 mm by visual estimation - Target lesion stenosis by visual estimation, assisted by QCA / IVUS: > 50% - < 100% - Eligible for Dual Anti Platelet Therapy (DAPT) Exclusion Criteria: - Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study - Evidence of myocardial infarction within 72 hours prior to index procedure - 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 - Unprotected left main coronary artery disease - Three-vessel coronary artery disease at time of procedure - Thrombus in target vessel - Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet - Planned interventional treatment of any non-target vessel within 30 days post-procedure - Subjects on dialysis - Planned intervention of the target vessel within 6-month after the index procedure - Ostial target lesion (within 5.0 mm of vessel origin) - Target lesion involves a side branch >2.0 mm in diameter - Documented left ventricular ejection fraction (LVEF) ≤ 30% - Heavily calcified lesion - Target lesion is located in or supplied by an arterial or venous bypass graft - The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to, rotational atherectomy, cutting balloon etc.) - Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material - Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention) - 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) - Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography - Life expectancy less than 1 year - Planned surgery or dental surgical procedure within 6 months after index procedure - In the investigators opinion subjects will not be able to comply with the follow-up requirements

Additional Information

Official title 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
Principal investigator Michael Haude, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Biotronik AG.