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

Coronary Artery Disease Clinical Trial

— BIOSOLVE-III  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716220
• Other study ID #: C1502
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 2019

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Percutaneous Coronary Intervention
Implanttaion fo the DREAMS 2G Scaffold

Locations

Country	Name	City	State
Belgium	Interventional Cardiology Middelheim Hospital (ZNA Middelheim)	Antwerp
Germany	Segeberger Kliniken GmbH	Bad Segeberg
Germany	Vivantes Klinikum Friederichshain,	Berlin
Germany	Amper Kliniken AG	Dachau
Germany	Städtische Kliniken Neuss	Neuss
Germany	Universitätsmedizin Rostock	Rostock
Netherlands	Thoraxcenter, Erasmus Medical Center	Rotterdam
Switzerland	Universitätsklinik Inselspitalspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Scaffold thrombosis rate		1, 6 12, 24 and 36 months post procedure
Secondary	Binary in-scaffold and in-segment restenosis rate		12-months
Secondary	% in-scaffold and in-segment diameter stenosis		12-months
Secondary	In-segment late lumen loss		12-months
Secondary	In-scaffold late lumen loss		12-months