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

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ClinicalTrials.gov Identifier: NCT02716220
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Stenosis Device: Percutaneous Coronary Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

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




Primary Outcome Measures :
  1. Acute performance of the DREAMS 2G [ Time Frame: During the hospital stay to a amximum of 7 days post study Procedure ]
    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


Secondary Outcome Measures :
  1. Target Lesion Failure (TLF) [ Time Frame: 1, 6 12, 24 and 36 months post procedure ]
    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)

  2. Scaffold thrombosis rate [ Time Frame: 1, 6 12, 24 and 36 months post procedure ]
  3. Binary in-scaffold and in-segment restenosis rate [ Time Frame: 12-months ]
  4. % in-scaffold and in-segment diameter stenosis [ Time Frame: 12-months ]
  5. In-segment late lumen loss [ Time Frame: 12-months ]
  6. In-scaffold late lumen loss [ Time Frame: 12-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716220


Locations
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Belgium
Interventional Cardiology Middelheim Hospital (ZNA Middelheim)
Antwerp, Belgium, 2020
Germany
Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795
Vivantes Klinikum Friederichshain,
Berlin, Germany, 10249
Amper Kliniken AG
Dachau, Germany, 85221
Städtische Kliniken Neuss
Neuss, Germany, 41464
Universitätsmedizin Rostock
Rostock, Germany, 18057
Netherlands
Thoraxcenter, Erasmus Medical Center
Rotterdam, Netherlands, 3015 CE
Switzerland
Universitätsklinik Inselspitalspital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
Biotronik AG
Investigators
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Principal Investigator: Michael Haude, MD Städtische Kliniken Neuss

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Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT02716220     History of Changes
Other Study ID Numbers: C1502
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Biotronik AG:
DREAMS 2G
Scaffold
Drug Eluting Absorbable Metal Scaffold
Coronary Artery Disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases