First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)

NCT01960504 | Unknown DMC

• 1 other identifier: C1209
• Study Type: interventional
• Target: 123
• Locations: 8 countries
• Sites: 13

Brief Summary

BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).

Conditions

Coronary Artery Disease; Coronary Artery Stenosis

Keywords

DREAMS; Drug Eluting Absorbable Metal Scaffold; Scaffold; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• In segment Late Lumen Loss

  6 months post index procedure

Secondary Outcomes (8)

• Target Lesion Failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularisation (TLR)

  1, 6, 12, 24 and 36 months

• Scaffold thrombosis rate

  1, 6, 12, 24 and 36 months

• In-scaffold and in-segment Binary Restenosis Rate

  6 and 12 months

• In-scaffold and in-segment Percent Diameter Stenosis

  6 and 12 months

• Late Lumen Loss in segment

  12 months

Study Arms (1)

Drug Eluting Absorbable Metal Scaffold

EXPERIMENTAL

DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold

Device: Percutaneous Coronary Intervention (DREAMS) stenting

Interventions

Percutaneous Coronary Intervention (DREAMS) stenting DEVICE

Also known as: DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold

Drug Eluting Absorbable Metal Scaffold

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is \> 18 years and \< 80 years of age
• 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)

You may not qualify if:

• Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
• 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

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (13)

OLV-Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012-909, Brazil

Location

Instituto do Coração - HCFMUSP

São Paulo, 05403-000, Brazil

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Segeberg Kliniken GmbH, Herzzentrum

Bad Segeberg, D-23795, Germany

Location

Vivantes Klinikum

Berlin, Germany

Location

Städtische Kliniken Neuss - Lukaskrankenhaus

Neuss, 41464, Germany

Location

Thoraxcentrum Twente

Enschede, 7513ER, Netherlands

Location

National Heart Centre Singapore

Mistri Wing, 168752, Singapore

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

University Hospital Basel

Basel, CH-4031, Switzerland

Location

CHUV - Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 33863661 DERIVED

• 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.

  PMID: 32093514 DERIVED

• 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.

  PMID: 30683424 DERIVED

• 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.

  PMID: 29292064 DERIVED

• 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.

  PMID: 27190094 DERIVED

• 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.

  PMID: 26470647 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Myocardial Ischemia; Atherosclerosis

Interventions

Percutaneous Coronary Intervention; Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Prostheses and Implants; Equipment and Supplies

Study Officials

• Michael Haude, MD

  Städtische Kliniken Neuss

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: May 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

DE (4); ES (1); CH (2); SG (1); BE (1); BR (2); NL (1); DK (1)