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First in Men Study: BIOMAG-I

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ClinicalTrials.gov Identifier: NCT04157153
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

Brief Summary:
A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold Not Applicable

Detailed Description:

Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter until 36 months post procedure.

All subjects will undergo an angiographic follow-up at 6- and 12-month follow up.

IVUS, (including IVUS-VH documentation) and OCT will be performed for all subjects at 6-month and 12-month follow-up (if the safety of the subject allows it and as per the investigator's decision).

Vasomotion will be assessed angiographically with Acetylcholine followed by Nitroglycerine at 12 months follow up in a subgroup of subjects, upon the investigators discretion and if subject consents.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BIOTRONIK - Safety and Clinical Performance of the - Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 36 monts.
Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold




Primary Outcome Measures :
  1. In scaffold late lumen loss [ Time Frame: At 6 months after index procedure ]
    Independent Core Lab Assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Subject eligible for PCI
  4. Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions and can be covered with 1 device each
  5. Reference vessel diameter between 2.5-4.2 mm by visual estimation, depending on the scaffold size used
  6. Target lesion length ≤ 28 mm by visual estimation, depending on the scaffold size used
  7. Target lesion stenosis by visual estimation > 50% - < 100% and TIMI flow ≥1 (assisted by e.g. QCA / IVUS /FFR).
  8. Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients without angiographic evidence of thrombus at target lesion
  9. 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. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure.
  3. Left main coronary artery disease
  4. Three-vessels with coronary artery disease requiring treatment at time of procedure
  5. Planned interventional treatment of any non-target vessel within 12-month post-procedure
  6. Subjects on dialysis
  7. Planned intervention of the target vessel post index procedure
  8. Ostial target lesion (within 5.0 mm of vessel origin)
  9. Target lesion involves a side branch >2.0 mm in diameter
  10. Documented left ventricular ejection fraction (LVEF) ≤ 30% within the last 6 months
  11. Heavily calcified lesion
  12. Target lesion is located in or supplied by an arterial or venous bypass graft
  13. Target lesion requiring treatment with a device other than the non-compliant pre-dilatation balloon or scoring balloon prior to scaffold placement (including but not limited to rotational atherectomy, etc.)
  14. Unsuccessful pre-dilatation, defined as a residual stenosis rate more than 20%, estimated by any method and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
  15. Known allergies to: Acetylsalicylic Acid (ASA), P2Y12 inhibitors, Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
  16. Subject is receiving an oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has a known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus) diabetes mellitus is not excluded)
  17. A stenosis located proximal or distal to the target lesion that might require future revascularization or an impede run off detected during diagnostic angiography
  18. Life expectancy less than 1 year
  19. Planned surgery or dental surgical procedure within 6 months after index procedure unless DAPT will be maintained
  20. In the investigators opinion, subject will not be able to comply with the follow-up requirements
  21. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet

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): NCT04157153


Contacts
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Contact: Stephanie Sauter, PhD +41448645575 ext 5575 stephanie.sauter@biotronik.com
Contact: Souheila Moutiq, Msc +41448645575 ext 5625 souheila.moutiq@biotronik.com

Locations
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Austria
Medizinische Universität Graz Not yet recruiting
Graz, Austria
Contact: Gabor Toth, MD         
Belgium
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium
Ziekenhuis Oost-Limburg Not yet recruiting
Genk, Belgium
Contact: Ferdinande Bert, MD         
UZ Leuven Gasthuisberg Not yet recruiting
Leuven, Belgium
Contact: Johann Bennett, MD         
Germany
Segeberger Kliniken
Bad Segeberg, Germany
Herz-und Gefäßzentrum Oberallgäu-Kempten Not yet recruiting
Kempten, Germany
Contact: Jan Torzewski, Prof         
Johannes Wesling Klinikum Minden Not yet recruiting
Minden, Germany
Contact: Marcus Wiemer, MD         
Deutsches Herzzentrum Not yet recruiting
Münich, Germany
Contact: Michael Joner, Prof         
Rheinland Klinikum Lukaskrankenhaus Neuss Not yet recruiting
Neuss, Germany
Contact: Michael Haude, Prof         
Netherlands
Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG) Not yet recruiting
Amsterdam, Netherlands
Contact: Rene van der Schaaf, MD         
Poland
Miedziowe Centrum Zdrowia SA Not yet recruiting
Lubin, Poland
Contact: Adrian Włodarczak, MD         
Spain
Hospital Clinico San Carlos Not yet recruiting
Madrid, Spain
Contact: Javier Escaned, MD         
Sweden
Lund University Hospital Not yet recruiting
Lund, Sweden
Contact: Göran Olivecrona, MD         
Switzerland
University Hospital Geneva HUG Not yet recruiting
Geneva, Switzerland
Contact: Juan Iglesias, MD         
Sponsors and Collaborators
Biotronik AG
Investigators
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Principal Investigator: Michael Haude, Prof Rheinland Klinikum Lukaskrankenhaus Neuss

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Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT04157153     History of Changes
Other Study ID Numbers: C1702
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs