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

Sponsor

Biotronik, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05540223

Collaborator

Biotronik AG (Industry), Biotronik Japan, Inc. (Industry)

1,728

Enrollment

Arms

Anticipated Duration (Months)

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
Coronary Artery Disease Atherosclerosis, Coronary Myocardial Ischemia Ischemic Heart Disease Acute Coronary Syndrome Angina Pectoris	Device: DREAMS 3G RMS Device: Xience DES	N/A

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:

Interventional

Anticipated Enrollment :

1728 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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	Device: DREAMS 3G RMS 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

Arm

Intervention/Treatment

Experimental: DREAMS 3G RMS

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

Device: DREAMS 3G RMS

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

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

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Clinical Inclusion Criteria:

Subject is > 18 years and < 80 years of age
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
Subject is eligible for PCI according to the applicable guidelines on myocardial revascularization
Subject is an acceptable candidate for coronary artery bypass surgery
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)
Subject is not contraindicated for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine.
Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)

Angiographic Inclusion Criteria:

Subjects with a maximum of two single de novo target lesions in up to two separate native coronary arteries
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)
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)
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.
Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1

Clinical Exclusion Criteria:

Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
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
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
Subject requires future peripheral interventions < 30 days after the index procedure unless DAPT regimen can be maintained.
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)
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).
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)
Life expectancy less than 1 year
Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained
In the investigator's opinion subject will not be able to comply with the follow-up requirements
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:

Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion
Left main coronary artery disease
Target lesion is totally occluded (100% stenosis)
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
Future planned staged PCI either in target or non-target vessel
Ostial target lesion (within 5.0 mm of vessel origin)
Target lesion involves a side branch that requires a 2-device strategy
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 or scoring balloon prior to scaffold/stent placement (including but not limited to drug-coated balloons, atherectomy devices, intravascular lithotripsy, etc.)
Target vessel was treated with brachytherapy any time prior to the index procedure
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)
Stenosis located proximal or distal to the target lesion that might require future revascularization or impede run off detected during diagnostic angiography