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

BIOTRONIK - Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects With de NOvo Lesions in NatiVE Coronary Arteries: BIOSOLVE-II

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).

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Coronary Artery Stenosis
• Intervention / Treatment: Device: Percutaneous Coronary Intervention (DREAMS) stenting

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • OLV-Ziekenhuis Aalst
• Brazil
  • São Paulo, Brazil, 04012-909
    • Instituto Dante Pazzanese de Cardiologia
  • São Paulo, Brazil, 05403-000
    • Instituto do Coracao - HCFMUSP
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
• Germany
  • Bad Krozingen, Germany, 79189
    • Universitäts-Herzzentrum Freiburg Bad Krozingen
  • Bad Segeberg, Germany, D-23795
    • Segeberg Kliniken GmbH, Herzzentrum
  • Berlin, Germany
    • Vivantes Klinikum
  • Neuss, Germany, 41464
    • Städtische Kliniken Neuss - Lukaskrankenhaus
• Netherlands
  • Enschede, Netherlands, 7513ER
    • Thoraxcentrum Twente
• Singapore
  • Mistri Wing, Singapore, 168752
    • National Heart Centre Singapore
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
• Switzerland
  • Basel, Switzerland, CH-4031
    • University Hospital Basel
  • Lausanne, Switzerland, 1011
    • CHUV - Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug Eluting Absorbable Metal Scaffold; DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold	Device: Percutaneous Coronary Intervention (DREAMS) stenting; Other Names: DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In segment Late Lumen Loss	6 months post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Late Lumen Loss in scaffold		6 and 12 months
Procedure success	Procedure Success defined as achievement of a final diameter stenosis of <30% by QCA, using any percutaneous method, without the occurrence of death, Q-wave or WHO defined non-Q-wave, or repeat revascularization of the target lesion during the hospital stay.	During the hospital stay to a maximum of the first seven days post index procedure
Device success	Device Success is defined as a final residual diameter stenosis of <30% by QCA, using the assigned device only; successful delivery of the scaffold to the target lesion site in the coronary artery; appropriate scaffold deployment; successful removal of the device; safe removal of the device in case of deployment failure	Day 0

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Principal Investigator: Michael Haude, MD, Städtische Kliniken Neuss

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: October 6, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Atherosclerosis; Myocardial Ischemia; Scaffold; DREAMS; Drug Eluting Absorbable Metal Scaffold
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: C1209