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

Not Applicable

• Conditions: Coronary Artery Stenosis; Coronary Artery Disease
• Interventions: Device: Percutaneous Coronary Intervention (DREAMS) stenting

• Registration Number: NCT01960504
• Lead Sponsor: Biotronik AG

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-06
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Primary Completion: 2015-08
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug Eluting Absorbable Metal Scaffold	Percutaneous Coronary Intervention (DREAMS) stenting	DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold

Primary Outcome Measures

Name	Time	Method
In segment Late Lumen Loss	6 months post index procedure

Secondary Outcome Measures

Name	Time	Method
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)	1, 6, 12, 24 and 36 months
Scaffold thrombosis rate	1, 6, 12, 24 and 36 months
Late Lumen Loss in scaffold	6 and 12 months
Procedure success	During the hospital stay to a maximum of the first seven days post index procedure	Procedure Success defined as achievement of a final diameter stenosis of \<30% by QCA, using any percutaneous method, without the occurrence of death, Q-wave or WHO defined non-Q-wave, or repeat revascularization of the target lesion during the hospital stay.
Device success	Day 0	Device Success is defined as a final residual diameter stenosis of \<30% by QCA, using the assigned device only; * successful delivery of the scaffold to the target lesion site in the coronary artery; * appropriate scaffold deployment; * successful removal of the device; * safe removal of the device in case of deployment failure
In-scaffold and in-segment Binary Restenosis Rate	6 and 12 months
In-scaffold and in-segment Percent Diameter Stenosis	6 and 12 months
Late Lumen Loss in segment	12 months

Trial Locations

Locations (13)

OLV-Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Städtische Kliniken Neuss - Lukaskrankenhaus; 🇩🇪 Neuss, Germany

Thoraxcentrum Twente; 🇳🇱 Enschede, Netherlands

National Heart Centre Singapore; 🇸🇬 Mistri Wing, Singapore

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 São Paulo, Brazil

Universitäts-Herzzentrum Freiburg Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Instituto do Coração - HCFMUSP; 🇧🇷 São Paulo, Brazil

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Segeberg Kliniken GmbH, Herzzentrum; 🇩🇪 Bad Segeberg, Germany

Vivantes Klinikum; 🇩🇪 Berlin, Germany

CHUV - Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland