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Clinical Trials/NL-OMON56825
NL-OMON56825
Completed
Not Applicable

BIOTRONIKS-Safety and Clinical Performance of the First Drug-Eluting Generation Absorbable Metal Stent In Patients with de Novo Lesions in Native Coronary Arteries (BIOSOLVE-I study) - BIOSOLVE-I Study

Biotronik AG0 sites10 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Biotronik AG
Enrollment
10
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Patient is between \>/\= 18 year and 2\. Written patient informed consent available prior to PCI
  • •3\. Patients with stable or unstable angina pectoris or documented silent ischemia
  • •4\. Patient eligible for PCI
  • •5\. Patient acceptable candidate for coronary artery bypass surgery
  • •6\. Patients with a maximum of two lesions in two separate coronary arteries which have to be de novo lesions.
  • •7\. Target reference vessel diameter by visual estimation, assisted by QCA / IVUS: 3\.0 \- 3\.5 mm
  • •8\. Target lesion length by visual estimation, assisted by QCA / IVUS: 9\. Target lesion stenosis by visual estimation, assisted by QCA / IVUS: \>/\= 50% \- \< 100%

Exclusion Criteria

  • •1\. Left ventricular ejection fraction of \< 30%
  • •2\. Patients with three\-vessel where all three vessels require treatment
  • •3\. Myocardial infarction (STEMI/NSTEMI) within 4 weeks of the intended treatment. Determination of CKMB and/or troponin T or I is required.
  • •Laboratory assessments to be done within 24 hours prior to intervention.
  • •Patients with CKMB and/or troponin T or I \> 3 fold the upper limit of normal must not be included in the trial.
  • •4\. Patients with risk of either acetylsalicylic acid, clopidogrel or Prasugrel cessation
  • •5\. Impaired renal function (serum creatinine \> 2\.0mg/dl or 177 umol/l, determined within 72 hours prior to intervention)
  • •6\. Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
  • •7\. Lesions located within arterial or venous graft
  • •8\. Ostial lesions

Outcomes

Primary Outcomes

Not specified

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