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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

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
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
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
months
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
required.
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
comply with the follow-up requirements
22.Subject is currently participating in another study with an investigational
device or an investigational drug and has not reached the primary endpoint yet