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

NCT ID: NCT02716220

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

'Percutaneous Coronary Intervention' /Scaffold Implantation

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

Group Type: EXPERIMENTAL

Percutaneous Coronary Intervention

Intervention Type: DEVICE

Implanttaion fo the DREAMS 2G Scaffold

Interventions

Percutaneous Coronary Intervention

Implanttaion fo the DREAMS 2G Scaffold

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Haude, MD

Role: PRINCIPAL_INVESTIGATOR

Städtische Kliniken Neuss

Locations

Thoraxcenter, Erasmus Medical Center

Rotterdam, , Netherlands

Universitätsklinik Inselspitalspital Bern

Bern, , Switzerland

Interventional Cardiology Middelheim Hospital (ZNA Middelheim)

Antwerp, , Belgium

Segeberger Kliniken GmbH

Bad Segeberg, , Germany

Vivantes Klinikum Friederichshain,

Berlin, , Germany

Amper Kliniken AG

Dachau, , Germany

Städtische Kliniken Neuss

Neuss, , Germany

Universitätsmedizin Rostock

Rostock, , Germany

Countries

Belgium; Germany; Netherlands; Switzerland

Other Identifiers

C1502

Identifier Type: -

Identifier Source: org_study_id