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Clinical Trials/NL-OMON41177
NL-OMON41177
Completed
Not Applicable

Study to evaluate the safety and feasibility of the STENTYS Balloon Delivery System (STENTYS-BDS). - SETUP

STENTYS0 sites20 target enrollmentTBD
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ConditionsCoronary artery stenosiscoronary atherosclerosis1001108210007593

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary artery stenosis
Sponsor
STENTYS
Enrollment
20
Status
Completed
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
Observational invasive

Investigators

Sponsor
STENTYS

Eligibility Criteria

Inclusion Criteria

  • •Age between 18 years and 80 years.
  • •2\. Patients with an indication to receive a STENTYS\-SES according to the IFU.\*
  • •3\. Signed Informed Consent.
  • •4\. Reference Vessel Diameter \>2\.5mm and \<6\.0mm by visual assessment.
  • •5\. Target lesion \*25mm in length by visual estimate.;\* Inclusion of STEMI patients allowed if sufficient time available for demanding written informed consent before stent placement.

Exclusion Criteria

  • •1\. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
  • •2\. Currently enrolled in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
  • •3\. Patients on anticoagulation therapy (Coumadin).
  • •4\. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, sirolimus, contrast material.
  • •5\. Known thrombocytopenia (PLT\<100,000/mm3\).
  • •6\. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy.
  • •7\. Cardiogenic shock.
  • •8\. Major planned surgery that requires discontinuation of dual antiplatelet therapy.
  • •9\. Co\-morbid condition(s) that could limit the subject\*s ability to participate in the study or to comply with follow\-up requirements, or impact the scientific integrity of the study ;Angiographic:
  • •10\. Severe tortuous, calcified or angulated coronary anatomy of the study vessel.

Outcomes

Primary Outcomes

Not specified

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