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Clinical Trials/NL-OMON52481
NL-OMON52481
Recruiting
Not 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

BIOTRONIK AG0 sites12 target enrollmentTBD
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Conditionscoronary stenosis- narrowing of the vessels (arteries) wich supply the hear with blood10011082

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
coronary stenosis- narrowing of the vessels (arteries) wich supply the hear with blood
Sponsor
BIOTRONIK AG
Enrollment
12
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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