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Clinical Trials/NL-OMON54209
NL-OMON54209
Recruiting
Not Applicable

Sirolimus-coated balloon versus drug-eluting stent in native coronary vessels - TRANSFORM II

Fondazione Ricerca e Innovazione Cardiovascolare, No profit organization0 sites315 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Fondazione Ricerca e Innovazione Cardiovascolare, No profit organization
Enrollment
315
Status
Recruiting
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

Sponsor
Fondazione Ricerca e Innovazione Cardiovascolare, No profit organization

Eligibility Criteria

Inclusion Criteria

  • •age \>18 years; \-all patients with a clinical indication to PCI (stable
  • •coronary arterydisease or acute coronary syndromes); \-native coronary artery
  • •lesion in a vessel with diameter \>2\.0 mm and \*3\.5 mm at visual estimation; \-
  • •maximum lesion lenght: 50 mm. \- informed consent to participate in the study

Exclusion Criteria

  • •target lesion/vessel with any of the following characteristics: \- concomitant
  • •PCI at the same vessel with any device (vessels are considered: left anterior
  • •descending, circumflex or right coronary artery); \- pre\-dilatation of the
  • •target lesion not performed or not successful (residual stenosis \>30%); \-
  • •severe calcification of the target vessel, at lesion site but also proximally;
  • •\- highly tortuous vessel which could impair device delivery to the lesion site
  • •following Investigator\*s judgement; \- previous stent implantation at target
  • •vessel (left anterior descending artery; circumflex artery; right coronary
  • •artery); \- bifurcation lesion where side branch treatment is anticipated; \-
  • •left main stem stenosis \>50%; \- target lesion is in left main stem. \-Lesion

Outcomes

Primary Outcomes

Not specified

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