NL-OMON52481RecruitingNot Applicable
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: BIOMAG-I - BIOMAG-I
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- BIOTRONIK AG
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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, according to the 2018 ESC/EACTS Guidelines on
- •myocardial revascularization.
- •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
- •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
- •NOTE: patient with acute STEMI can not be included in the study (according to
- •exclusion criteria 2)
- •9. Subject who has no contraindication 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 electrocardiogram (ECG) changes consistent
- •with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to
- •the index procedure.
- •NOTE: after 72 hours, any lesion other than the one causing the acute STEMI
- •(culprit lesion) in any other epicardial vessel, may be treated according to
- •the inclusion and exclusion criteria
- •3. Left main coronary artery disease
- •4. Three-vessels with coronary artery disease requiring treatment at time of
- •procedure, including: left main, left anterior descending artery (LAD) right
- •coronary artery (RCA) and circumflex coronary artery (Cx)
- •5. Planned interventional treatment of any non-target vessel within 12-month
- •post-procedure
- •6. Subjects on dialysis
- •7. Impaired renal function (serum creatinine > 2.5 mg/dl or 221 µmol/l,
- •determined within 72 hours prior to intervention)
- •8. Planned future intervention of a second lesion within the target vessel.
- •9. Ostial target lesion (within 5.0 mm of vessel origin)
- •10.Target lesion involves a side branch >2.0 mm in diameter
- •11.Documented left ventricular ejection fraction (LVEF) <= 30% within the last 6
- •12.Heavily calcified lesion which can not be adequately pre-dilated by a
- •non-compliant and/ or scoring balloon as described in exclusion criteria 15.
- •13.Target lesion is located in or supplied by an arterial or venous bypass graft
- •14.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.)
- •15.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)
- •16.Known allergies or intolerances to: Acetylsalicylic Acid (ASA), P2Y12
- •inhibitors, Heparin, Contrast medium, Sirolimus, or similar drugs; or the
- •scaffold material (Magnesium, Aluminium)
- •17.Subject is receiving an oral or intravenous immunosuppressive 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)
- •18.Life expectancy less than 1 year
- •19.Subjects under oral anticoagulation therapy (OAC) prior to implantation of
- •DREAMS 3G unless DAPT can be maintained for a minimum of 6-month.
- •Recommendation: If a subject requires OAC after DREAMS 3G implantation, DAPT
- •should be maintained until 6 months follow up. Afterwards DAPT can be downsized
- •to either ASA or Clopidogrel alone together with OAC for the remaining time
- •period up to 12 months. After this, OAC monotherapy can be prescribed if still
- •20.Planned surgery or dental surgical procedure within 6 months after index
- •procedure unless DAPT will be maintained
- •21.In the investigators opinion, subject will not be able to
- +3 more not shown
Investigators
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