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

BIOTRONIKS - Acute Performance Of a Drug Eluting Absorbable Metal Scaffold (DREAMS 2G) in Patients With de Novo Lesions in NatiVE Coronary Arteries: BIOSOLVE-III

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Artery Stenosis
• Intervention / Treatment: Device: Percutaneous Coronary Intervention

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • Interventional Cardiology Middelheim Hospital (ZNA Middelheim)
• Germany
  • Bad Segeberg, Germany, 23795
    • Segeberger Kliniken GmbH
  • Berlin, Germany, 10249
    • Vivantes Klinikum Friederichshain,
  • Dachau, Germany, 85221
    • Amper Kliniken AG
  • Neuss, Germany, 41464
    • Städtische Kliniken Neuss
  • Rostock, Germany, 18057
    • Universitätsmedizin Rostock
• Netherlands
  • Rotterdam, Netherlands, 3015 CE
    • Thoraxcenter, Erasmus Medical Center
• Switzerland
  • Bern, Switzerland, 3010
    • Universitätsklinik Inselspitalspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is > 18 years and < 80 years of age
2. Written subject informed consent available prior to PCI
3. Subjects with stable or unstable angina pectoris or documented silent ischemia
4. Subject eligible for PCI
5. Subject acceptable candidate for coronary artery bypass surgery
6. Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
7. Reference vessel diameter between 2.7-3.8 mm by visual estimation, depending on the scaffold size used.
8. Target lesion length by visual estimation, assisted by QCA: < 21 mm, depending on the scaffold size used.
9. Target lesion stenosis by visual estimation, assisted by QCA > 50% - < 100%
10. Eligible for Dual Anti Platelet Therapy (DAPT)

Exclusion Criteria:

1. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
2. Evidence of myocardial infarction within 72 hours prior to index procedure
3. 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
4. Left main coronary artery disease
5. Three-vessel coronary artery disease at time of procedure
6. Thrombus in target vessel
7. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
8. Planned interventional treatment of any non-target vessel within 30 days post procedure
9. Subjects on dialysis
10. Planned intervention of the target vessel after the index procedure
11. Ostial target lesion (within 5.0 mm of vessel origin)
12. Target lesion involves a side branch >2.0 mm in diameter
13. Documented left ventricular ejection fraction (LVEF) ≤ 30%
14. Heavily calcified lesion
15. Target lesion is located in or supplied by an arterial or venous bypass graft
16. The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
17. Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of DREAMS 2G and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections that can't be covered by a single scaffold), by visual estimation
18. Known allergies to: Acetylsalicylic Acid (ASA), Heparin, contrast medium, Sirolimus, Everolimus or similar drugs (i.e., ABT 578, Biolimus, Tacrolimus), PLLA, Silicon Carbide Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum
19. Impaired renal function (serum creatinine > 2.5 mg/dl or 221mmol/l) determined within 72 hours prior to intervention
20. Subject is receiving oral or intravenous immuno-suppressive therapy ( 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)
21. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
22. Life expectancy less than 1 year, or other co-morbidities (e.g. Sepsis, Apoplexy or TIA within 6 months prior to the study procedure) (Co-morbidities definitions will be left to the discretion of the Study Investigators)
23. Planned surgery or dental surgical procedure within 6 months after index procedure
24. Subject with tortuous vessel that may impair scaffold placement in the region of obstruction or proximal to the lesion
25. In the investigators opinion subjects will not be able to comply with the follow-up Requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 'Percutaneous Coronary Intervention' /Scaffold Implantation; PCI for enrolled subjects: implantation of the DREAMS 2G Drug-Eluting Coronary Scaffold System	Device: Percutaneous Coronary Intervention; Implanttaion fo the DREAMS 2G Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF)	TLF defined as a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave Myocardial Infarction (MI)**, Coronary Artery Bypass Grafting (CABG), clinically driven Target Lesion Revascularization (TLR)	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
In-scaffold late lumen loss		12-months

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Principal Investigator: Michael Haude, MD, Städtische Kliniken Neuss

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Scaffold; Drug Eluting Absorbable Metal Scaffold; DREAMS 2G
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: C1502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No