BIOMAG-II: Safety and Clinical Performance of the DREAMS 3G Resorbable Magnesium Scaffold System

Biotronik, Inc. (Industry)
Overall Status
Not yet recruiting ID
Biotronik AG (Industry), Biotronik Japan, Inc. (Industry)

Study Details

Study Description

Brief Summary

The objective of this study is to assess the safety and efficacy of the DREAMS 3G in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).

Condition or Disease Intervention/Treatment Phase
  • Device: DREAMS 3G RMS
  • Device: Xience DES

Detailed Description

The Biotronik BIOMAG-II clinical trial is a prospective, international, multi-center, randomized controlled, non-inferiority trial to compare the BIOTRONIK Sirolimus Eluting Resorbable Magnesium Scaffold System (DREAMS 3G RMS) with the Xience Everolimus Eluting Stent System (Xience DES) with respect to Target Lesion Failure (TLF) rate at 12 months. A total of 1728 subjects will be enrolled at approximately 120 study sites worldwide. Subjects will be randomized in a 2:1 ratio to DREAMS 3G or Xience.

Clinical follow-up visits will take place at 1, 6, 12 and 18 months and at 2-, 3-, 4- and 5-years post procedure.

Study Design

Study Type:
Anticipated Enrollment :
1728 participants
Intervention Model:
Parallel Assignment
Single (Outcomes Assessor)
Primary Purpose:
Official Title:
BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable Coronary MAGnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries: BIOMAG-II: A Randomized Controlled Trial
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: DREAMS 3G RMS

Intervention with a DREAMS 3G Sirolimus Eluting Resorbable Coronary Magnesium Scaffold System

Subject undergoes implantation of DREAMS 3G RMS
Other Names:
  • DREAMS 3G Sirolimus Eluting Resorbable Coronary Magnesium Scaffold System
  • Active Comparator: Xience DES

    Intervention with a Xience Everolimus Eluting Stent System

    Device: Xience DES
    Subject undergoes implantation of Xience DES
    Other Names:
  • Xience Everolimus Eluting Stent System
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure [12 Months]

      The primary endpoint will be Target Lesion Failure (TLF) at 12 months. TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Lesion Revascularization (TLR).

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Clinical Inclusion Criteria:
    1. Subject is > 18 years and < 80 years of age

    2. Subject has provided written informed consent as approved by the Ethical Committee (EC) or Institutional Review Committee (IRB) of the respective clinical site prior to the study related procedures

    3. Subject is eligible for PCI according to the applicable guidelines on myocardial revascularization

    4. Subject is an acceptable candidate for coronary artery bypass surgery

    5. Subjects with stable or unstable angina pectoris, documented silent ischemia or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion Note: Subjects with acute ST elevation myocardial infarction (STEMI) cannot be included in the study (see clinical exclusion criteria 2)

    6. Subject is not contraindicated for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine.

    7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)

    Angiographic Inclusion Criteria:
    1. Subjects with a maximum of two single de novo target lesions in up to two separate native coronary arteries

    2. Target vessel must have a reference diameter between 2.5-4.2 mm by operator visual estimate or by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT)

    3. Target lesion must be ≤36 mm in length by operator visual estimate, and can be treated with one study device (only one scaffold/stent allowed per lesion)

    4. Target lesion stenosis > 50% and < 100% by visual estimation, assisted by QCA or / IVUS. If the target lesion is < 70% stenosed, there should be clinical evidence of ischemia such as a positive functional study (e.g. exercise treadmill test, thallium stress test, SPECT, or stress echo), cardiac computed tomography (CT), electrocardiography, fractional flow reserve, or post infarct angina.

    5. Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1

    Clinical Exclusion Criteria:
    1. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study

    2. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with STEMI within 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment Note: After 72 hours, any lesion other than the one causing the acute STEMI (culprit lesion) in any other epicardial vessel, may be treated if the subject and lesion meet inclusion and no exclusion criteria

    3. Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure. Prior PCI within a non-target vessel or any peripheral intervention is acceptable if performed anytime > 30 days before the index procedure

    4. Subject requires future peripheral interventions < 30 days after the index procedure unless DAPT regimen can be maintained.

    5. Subject is on dialysis or impaired renal function (serum creatinine > 2.5 mg/dl or 221 μmol/L, determined within 72 hours prior to the index procedure)

    6. Allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel, prasugrel, ticagrelor or ticlopidine; or to heparin and bivalirudin; contrast media that cannot be resolved with pre-medication; sirolimus, everolimus, or similar limus drugs; poly L-lactide, or the scaffold material (magnesium, aluminum) or Xience stent (cobalt, chromium, tungsten, nickel, fluorinated copolymer).

    7. Subject is receiving oral or intravenous immunosuppressive 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)

    8. Life expectancy less than 1 year

    9. Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained

    10. In the investigator's opinion subject will not be able to comply with the follow-up requirements

    11. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT

    • OAC (i.e. triple therapy) can be maintained for a minimum of 6 months If a subject requires OAC after the index procedure, DAPT should be maintained until 6 months after the index procedure. Afterwards DAPT can be limited to either aspirin or clopidogrel (or prasugrel, ticagrelor or ticlopidine) alone together with OAC for the remaining time up to 12 months. After this, OAC monotherapy can be prescribed if still required.
    Angiographic Exclusion Criteria:
    1. Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion

    2. Left main coronary artery disease

    3. Target lesion is totally occluded (100% stenosis)

    4. Thrombus in target vessel

    5. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet

    6. Future planned staged PCI either in target or non-target vessel

    7. Ostial target lesion (within 5.0 mm of vessel origin)

    8. Target lesion involves a side branch that requires a 2-device strategy

    9. Target lesion is located in or supplied by an arterial or venous bypass graft

    10. The target lesion requires treatment with a device other than the pre-dilatation balloon or scoring balloon prior to scaffold/stent placement (including but not limited to drug-coated balloons, atherectomy devices, intravascular lithotripsy, etc.)

    11. Target vessel was treated with brachytherapy any time prior to the index procedure

    12. Unsuccessful pre-dilatation, defined as residual stenosis rate more than 20% (by visual estimation) and / or angiographic complications (e.g. distal embolization, side branch closure, flow-limiting dissections)

    13. Stenosis located proximal or distal to the target lesion that might require future revascularization or impede run off detected during diagnostic angiography

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Biotronik, Inc.
    • Biotronik AG
    • Biotronik Japan, Inc.


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Biotronik, Inc. Identifier:
    Other Study ID Numbers:
    • C1801
    First Posted:
    Sep 14, 2022
    Last Update Posted:
    Sep 14, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Keywords provided by Biotronik, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2022