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

Primary Purpose

Coronary Artery Disease, Coronary Artery Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention (DREAMS) stenting
Sponsored by
Biotronik AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring DREAMS, Drug Eluting Absorbable Metal Scaffold, Scaffold, Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OLV-Ziekenhuis Aalst
  • Instituto Dante Pazzanese de Cardiologia
  • Instituto do Coração - HCFMUSP
  • Aarhus University Hospital
  • Universitäts-Herzzentrum Freiburg Bad Krozingen
  • Segeberg Kliniken GmbH, Herzzentrum
  • Vivantes Klinikum
  • Städtische Kliniken Neuss - Lukaskrankenhaus
  • Thoraxcentrum Twente
  • National Heart Centre Singapore
  • Hospital Clinico San Carlos
  • University Hospital Basel
  • CHUV - Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug Eluting Absorbable Metal Scaffold

Arm Description

DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold

Outcomes

Primary Outcome Measures

In segment Late Lumen Loss

Secondary Outcome Measures

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)
Scaffold thrombosis rate
In-scaffold and in-segment Binary Restenosis Rate
In-scaffold and in-segment Percent Diameter Stenosis
Late Lumen Loss in segment
Late Lumen Loss in scaffold
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.
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

Full Information

First Posted
October 6, 2013
Last Updated
January 14, 2020
Sponsor
Biotronik AG
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1. Study Identification

Unique Protocol Identification Number
NCT01960504
Brief Title
First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)
Acronym
BIOSOLVE-II
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Stenosis
Keywords
DREAMS, Drug Eluting Absorbable Metal Scaffold, Scaffold, Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Eluting Absorbable Metal Scaffold
Arm Type
Experimental
Arm Description
DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold
Intervention Type
Device
Intervention Name(s)
Percutaneous Coronary Intervention (DREAMS) stenting
Other Intervention Name(s)
DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold
Primary Outcome Measure Information:
Title
In segment Late Lumen Loss
Time Frame
6 months post index procedure
Secondary Outcome Measure Information:
Title
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)
Time Frame
1, 6, 12, 24 and 36 months
Title
Scaffold thrombosis rate
Time Frame
1, 6, 12, 24 and 36 months
Title
In-scaffold and in-segment Binary Restenosis Rate
Time Frame
6 and 12 months
Title
In-scaffold and in-segment Percent Diameter Stenosis
Time Frame
6 and 12 months
Title
Late Lumen Loss in segment
Time Frame
12 months
Title
Late Lumen Loss in scaffold
Time Frame
6 and 12 months
Title
Procedure success
Description
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.
Time Frame
During the hospital stay to a maximum of the first seven days post index procedure
Title
Device success
Description
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
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Haude, MD
Organizational Affiliation
Städtische Kliniken Neuss
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLV-Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Facility Name
Instituto do Coração - HCFMUSP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Universitäts-Herzzentrum Freiburg Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Segeberg Kliniken GmbH, Herzzentrum
City
Bad Segeberg
ZIP/Postal Code
D-23795
Country
Germany
Facility Name
Vivantes Klinikum
City
Berlin
Country
Germany
Facility Name
Städtische Kliniken Neuss - Lukaskrankenhaus
City
Neuss
ZIP/Postal Code
41464
Country
Germany
Facility Name
Thoraxcentrum Twente
City
Enschede
ZIP/Postal Code
7513ER
Country
Netherlands
Facility Name
National Heart Centre Singapore
City
Mistri Wing
ZIP/Postal Code
168752
Country
Singapore
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
CHUV - Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33863661
Citation
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.
Results Reference
derived
PubMed Identifier
32093514
Citation
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.
Results Reference
derived
PubMed Identifier
30683424
Citation
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.
Results Reference
derived
PubMed Identifier
29292064
Citation
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.
Results Reference
derived
PubMed Identifier
27190094
Citation
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.
Results Reference
derived
PubMed Identifier
26470647
Citation
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.
Results Reference
derived

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

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