First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)

Biotronik

Status

Unknown

Conditions

Coronary Artery Disease

Coronary Artery Stenosis

Treatments

Device: Percutaneous Coronary Intervention (DREAMS) stenting

Study type

Interventional

Funder types

Industry

Identifiers

NCT01960504

C1209

Details and patient eligibility

About

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).

Enrollment

123 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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