First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)
NCT ID: NCT01960504
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
123 participants
INTERVENTIONAL
2013-10-31
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Drug Eluting Absorbable Metal Scaffold
DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold
Percutaneous Coronary Intervention (DREAMS) stenting
Interventions
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Percutaneous Coronary Intervention (DREAMS) stenting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written subject informed consent available prior to PCI
* Subjects with stable or unstable angina pectoris or documented silent ischemia
* Subject eligible for PCI
* Subject acceptable candidate for coronary artery bypass surgery
* Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
* Reference vessel diameter between 2.2-3.8 mm by visual estimation
* Target lesion length ≤ 21 mm by visual estimation
* Target lesion stenosis by visual estimation, assisted by QCA / IVUS: \> 50% - \< 100%
* Eligible for Dual Anti Platelet Therapy (DAPT)
Exclusion Criteria
* Evidence of myocardial infarction within 72 hours prior to index procedure
* 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
* Unprotected left main coronary artery disease
* Three-vessel coronary artery disease at time of procedure
* Thrombus in target vessel
* Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
* Planned interventional treatment of any non-target vessel within 30 days post-procedure
* Subjects on dialysis
* Planned intervention of the target vessel within 6-month after the index procedure
* Ostial target lesion (within 5.0 mm of vessel origin)
* Target lesion involves a side branch \>2.0 mm in diameter
* Documented left ventricular ejection fraction (LVEF) ≤ 30%
* Heavily calcified lesion
* Target lesion is located in or supplied by an arterial or venous bypass graft
* The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to, rotational atherectomy, cutting balloon etc.)
* Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
* Impaired renal function (serum creatinine \> 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
* Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., 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)
* Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
* Life expectancy less than 1 year
* Planned surgery or dental surgical procedure within 6 months after index procedure
* In the investigators opinion subjects will not be able to comply with the follow-up requirements
18 Years
80 Years
ALL
No
Sponsors
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Biotronik AG
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Haude, MD
Role: PRINCIPAL_INVESTIGATOR
Städtische Kliniken Neuss
Locations
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OLV-Ziekenhuis Aalst
Aalst, , Belgium
Instituto Dante Pazzanese de Cardiologia
São Paulo, , Brazil
Instituto do Coração - HCFMUSP
São Paulo, , Brazil
Aarhus University Hospital
Aarhus, , Denmark
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, , Germany
Segeberg Kliniken GmbH, Herzzentrum
Bad Segeberg, , Germany
Vivantes Klinikum
Berlin, , Germany
Städtische Kliniken Neuss - Lukaskrankenhaus
Neuss, , Germany
Thoraxcentrum Twente
Enschede, , Netherlands
National Heart Centre Singapore
Mistri Wing, , Singapore
Hospital Clinico San Carlos
Madrid, , Spain
University Hospital Basel
Basel, , Switzerland
CHUV - Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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References
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Ozaki Y, Kuku KO, Sakellarios A, Haude M, Hideo-Kajita A, Desale S, Siogkas P, Sioros S, Ince H, Abizaid A, Tolg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Escaned J, Michalis L, Fotiadis DI, Djikstra J, Waksman R, Garcia-Garcia HM. Impact of Endothelial Shear Stress on Absorption Process of Resorbable Magnesium Scaffold: A BIOSOLVE-II Substudy. Cardiovasc Revasc Med. 2021 Aug;29:9-15. doi: 10.1016/j.carrev.2021.04.003. Epub 2021 Apr 9.
Ueki Y, Raber L, Otsuka T, Rai H, Losdat S, Windecker S, Garcia-Garcia HM, Landmesser U, Koolen J, Byrne R, Haude M, Joner M. Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis: A Serial Optical Coherence Tomography Study. Circ Cardiovasc Interv. 2020 Mar;13(3):e008657. doi: 10.1161/CIRCINTERVENTIONS.119.008657. Epub 2020 Feb 25.
Ozaki Y, Garcia-Garcia HM, Hideo-Kajita A, Kuku KO, Haude M, Ince H, Abizaid A, Tolg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Escaned J, Waksman R. Serial 3-Dimensional Optical Coherence Tomography Assessment of Jailed Side-Branch by Second-Generation Drug-Eluting Absorbable Metal Scaffold (from the BIOSOLVE-II Trial). Am J Cardiol. 2019 Apr 1;123(7):1044-1051. doi: 10.1016/j.amjcard.2018.12.029. Epub 2019 Jan 4.
Garcia-Garcia HM, Haude M, Kuku K, Hideo-Kajita A, Ince H, Abizaid A, Tolg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Escaned J, Dijkstra J, Waksman R. In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris - DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial. Int J Cardiol. 2018 Mar 15;255:22-28. doi: 10.1016/j.ijcard.2017.12.053. Epub 2017 Dec 28.
Haude M, Ince H, Abizaid A, Toelg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Neumann FJ, Kaiser C, Eeckhout E, Lim ST, Escaned J, Onuma Y, Garcia-Garcia HM, Waksman R. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. Eur Heart J. 2016 Sep 14;37(35):2701-9. doi: 10.1093/eurheartj/ehw196. Epub 2016 May 17.
Haude M, Ince H, Abizaid A, Toelg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Neumann FJ, Kaiser C, Eeckhout E, Lim ST, Escaned J, Garcia-Garcia HM, Waksman R. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet. 2016 Jan 2;387(10013):31-9. doi: 10.1016/S0140-6736(15)00447-X. Epub 2015 Oct 12.
Other Identifiers
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C1209
Identifier Type: -
Identifier Source: org_study_id
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