Overview

This trial is active, not recruiting.

Conditions coronary artery disease, coronary artery stenosis
Treatment percutaneous coronary intervention
Sponsor Biotronik AG
Start date March 2016
End date October 2016
Trial size 61 participants
Trial identifier NCT02716220, C1502

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
PCI for enrolled subjects: implantation of the DREAMS 2G Drug-Eluting Coronary Scaffold System
percutaneous coronary intervention
Implanttaion fo the DREAMS 2G Scaffold

Primary Outcomes

Measure
Acute performance of the DREAMS 2G
time frame: During the hospital stay to a amximum of 7 days post study Procedure

Secondary Outcomes

Measure
Target Lesion Failure (TLF)
time frame: 1, 6 12, 24 and 36 months post procedure
Scaffold thrombosis rate
time frame: 1, 6 12, 24 and 36 months post procedure
Binary in-scaffold and in-segment restenosis rate
time frame: 12-months
% in-scaffold and in-segment diameter stenosis
time frame: 12-months
In-segment late lumen loss
time frame: 12-months
In-scaffold late lumen loss
time frame: 12-months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Michael Haude, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Biotronik AG.