Pre-market Study of the DREAMS 2G Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-III)

NCT02716220 | Completed DMC

• 1 other identifier: C1502
• Study Type: interventional
• Target: 61
• Locations: 4 countries
• Sites: 8

Brief Summary

BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary artery lesions.

Conditions

Coronary Artery Disease; Coronary Artery Stenosis

Keywords

DREAMS 2G; Scaffold; Drug Eluting Absorbable Metal Scaffold; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Acute performance of the DREAMS 2G

  Acute performance of the DREAMS 2G assessed by procedure success. Procedure success is defined as: Procedure Success is defined as achievement of a final diameter stenosis of \<30% by QCA (using any percutaneous method) without the occurrence of death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay

  During the hospital stay to a maximum of 7 days post study Procedure

Secondary Outcomes (6)

• Target Lesion Failure (TLF)

  1, 6 12, 24 and 36 months post procedure

• Scaffold thrombosis rate

  1, 6 12, 24 and 36 months post procedure

• Binary in-scaffold and in-segment restenosis rate

  12-months

• % in-scaffold and in-segment diameter stenosis

  12-months

• In-segment late lumen loss

  12-months

Study Arms (1)

'Percutaneous Coronary Intervention' /Scaffold Implantation

EXPERIMENTAL

PCI for enrolled subjects: implantation of the DREAMS 2G Drug-Eluting Coronary Scaffold System

Device: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention DEVICE

Implanttaion fo the DREAMS 2G Scaffold

'Percutaneous Coronary Intervention' /Scaffold Implantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2.7-3.8 mm by visual estimation, depending on the scaffold size used.
• Target lesion length by visual estimation, assisted by QCA: \< 21 mm, depending on the scaffold size used.
• Target lesion stenosis by visual estimation, assisted by QCA \> 50% - \< 100%
• Eligible for Dual Anti Platelet Therapy (DAPT)

You may not qualify if:

• 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
• 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 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

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (8)

Interventional Cardiology Middelheim Hospital (ZNA Middelheim)

Antwerp, 2020, Belgium

Location

Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Vivantes Klinikum Friederichshain,

Berlin, 10249, Germany

Location

Amper Kliniken AG

Dachau, 85221, Germany

Location

Städtische Kliniken Neuss

Neuss, 41464, Germany

Location

Universitätsmedizin Rostock

Rostock, 18057, Germany

Location

Thoraxcenter, Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Universitätsklinik Inselspitalspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Michael Haude, MD

  Städtische Kliniken Neuss

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: August 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); CH (1); NL (1); BE (1)