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

Coronary Artery Disease Clinical Trial

— BIOSOLVE-II  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01960504
• Other study ID #: C1209
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: May 2020

Study information

• Verified date: January 2020
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: May 2020
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Device:
• Percutaneous Coronary Intervention (DREAMS) stenting

Locations

Country	Name	City	State
Belgium	OLV-Ziekenhuis Aalst	Aalst
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo
Brazil	Instituto do Coração - HCFMUSP	São Paulo
Denmark	Aarhus University Hospital	Aarhus
Germany	Universitäts-Herzzentrum Freiburg Bad Krozingen	Bad Krozingen
Germany	Segeberg Kliniken GmbH, Herzzentrum	Bad Segeberg
Germany	Vivantes Klinikum	Berlin
Germany	Städtische Kliniken Neuss - Lukaskrankenhaus	Neuss
Netherlands	Thoraxcentrum Twente	Enschede
Singapore	National Heart Centre Singapore	Mistri Wing
Spain	Hospital Clinico San Carlos	Madrid
Switzerland	University Hospital Basel	Basel
Switzerland	CHUV - Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Belgium,  Brazil,  Denmark,  Germany,  Netherlands,  Singapore,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In segment Late Lumen Loss		6 months post index procedure
Secondary	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
Secondary	Scaffold thrombosis rate		1, 6, 12, 24 and 36 months
Secondary	In-scaffold and in-segment Binary Restenosis Rate		6 and 12 months
Secondary	In-scaffold and in-segment Percent Diameter Stenosis		6 and 12 months
Secondary	Late Lumen Loss in segment		12 months
Secondary	Late Lumen Loss in scaffold		6 and 12 months
Secondary	Procedure success	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.	During the hospital stay to a maximum of the first seven days post index procedure
Secondary	Device success	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	Day 0