- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157153
First in Men Study: BIOMAG-I
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter until 60 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Graz, Austria
- Medizinische Universität Graz
-
-
-
-
-
Antwerp, Belgium
- Algemeen Ziekenhuis Middelheim
-
Genk, Belgium
- Ziekenhuis Oost-Limburg
-
Leuven, Belgium
- UZ Leuven Gasthuisberg
-
-
-
-
-
Bad Segeberg, Germany
- Segeberger Kliniken
-
Kempten, Germany
- Herz-und Gefäßzentrum Oberallgäu-Kempten
-
Minden, Germany
- Johannes Wesling Klinikum Minden
-
Münich, Germany
- Deutsches Herzzentrum
-
Neuss, Germany
- Rheinland Klinikum Lukaskrankenhaus Neuss
-
-
-
-
-
Amsterdam, Netherlands
- Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)
-
-
-
-
-
Lubin, Poland
- Miedziowe Centrum Zdrowia SA
-
-
-
-
-
Madrid, Spain
- Hospital Clinico San Carlos
-
-
-
-
-
Lund, Sweden
- Lund University Hospital
-
-
-
-
-
Geneva, Switzerland
- University Hospital Geneva HUG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is > 18 years and < 80 years of age
- Written subject informed consent available prior to PCI
- Subject eligible for PCI
- 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
- Reference vessel diameter between 2.5-4.2 mm by visual estimation, depending on the scaffold size used
- Target lesion length ≤ 28 mm by visual estimation, depending on the scaffold size used
- Target lesion stenosis by visual estimation > 50% - < 100% and TIMI flow ≥1 (assisted by e.g. QCA / IVUS /FFR).
- Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients without angiographic evidence of thrombus at target lesion
- 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
- 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.
- Left main coronary artery disease
- Three-vessels with coronary artery disease requiring treatment at time of procedure
- Planned interventional treatment of any non-target vessel within 12-month post-procedure
- Subjects on dialysis
- Planned intervention of the target vessel post 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% within the last 6 months
- Heavily calcified lesion
- Target lesion is located in or supplied by an arterial or venous bypass graft
- 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.)
- 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)
- Known allergies to: Acetylsalicylic Acid (ASA), P2Y12 inhibitors, Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
- 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)
- A stenosis located proximal or distal to the target lesion that might require future revascularization or an 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 unless DAPT will be maintained
- In the investigators opinion, subject will not be able to comply with the follow-up requirements
- Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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 60 months.
|
Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In scaffold late lumen loss
Time Frame: At 6 months after index procedure
|
Independent Core Lab Assessment
|
At 6 months after index procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Haude, Prof, Rheinland Klinikum Lukaskrankenhaus Neuss
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- C1702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
-
Biotronik AGCBCC-VIBGYOR Research Pvt. Ltd.SuspendedCoronary Artery DiseaseIndia
-
480 BiomedicalCompletedCardiovascular Diseases | Vascular Diseases | Peripheral Arterial Disease | Intermittent ClaudicationNew Zealand, Switzerland, Austria, Germany
-
Raul MorenoCompletedCoronary Artery Disease | Percutaneous Coronary Intervention | Coronary Occlusion
-
Biotronik AGBiotronik AGNot yet recruitingMyocardial Ischemia | Coronary Artery Disease | Angina Pectoris | Acute Coronary Syndrome | Ischemic Heart Disease | Atherosclerosis, Coronary
-
University of FreiburgCompletedCoronary Artery DiseaseSwitzerland
-
Meril Life Sciences Pvt. Ltd.Not yet recruiting
-
REVA Medical, Inc.Active, not recruitingCoronary Artery DiseaseNetherlands, Denmark, Poland, Germany, Australia, France, Belgium, Brazil
-
Meril Life Sciences Pvt. Ltd.UnknownCoronary Artery DiseaseUnited Kingdom, Brazil, Spain, Macedonia, The Former Yugoslav Republic of, Belgium, Czechia, Latvia, Netherlands, Poland
-
Meril Life Sciences Pvt. Ltd.Not yet recruitingCoronary Artery Disease