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First in Men Study: BIOMAG-I

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 6, 2019
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date November 8, 2019
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
In scaffold late lumen loss [ Time Frame: At 6 months after index procedure ]
Independent Core Lab Assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First in Men Study: BIOMAG-I
Official Title  ICMJE 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
Brief Summary A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Treatment
All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 36 monts.
Intervention: Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2019)
115
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephanie Sauter, PhD +41448645575 ext 5575 stephanie.sauter@biotronik.com
Contact: Souheila Moutiq, Msc +41448645575 ext 5625 souheila.moutiq@biotronik.com
Listed Location Countries  ICMJE Austria,   Belgium,   Germany,   Netherlands,   Poland,   Spain,   Sweden,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04157153
Other Study ID Numbers  ICMJE C1702
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biotronik AG
Study Sponsor  ICMJE Biotronik AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Haude, Prof Rheinland Klinikum Lukaskrankenhaus Neuss
PRS Account Biotronik AG
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP