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Clinical Trials/NCT03471234
NCT03471234
Completed
Not Applicable

LATIn American sTUdy to Investigate the Clinical Performance of Sirolimus-eluting Stent With Abluminal-only bioDEgradable Polymeric Coating (Inspiron TM) in the Treatment of Native Coronary Artery Lesions.

Scitech Produtos Medicos Ltda2 sites in 1 country299 target enrollmentSeptember 3, 2018
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ConditionsCoronary Artery Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Scitech Produtos Medicos Ltda
Enrollment
299
Locations
2
Primary Endpoint
MACE (major cardiac events)
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.

Detailed Description

Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of "real world" patients.

Registry
clinicaltrials.gov
Start Date
September 3, 2018
End Date
August 2, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Scitech Produtos Medicos Ltda
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent.

Exclusion Criteria

  • •Saphenous vein grafts or Mammary lesions;
  • •Individuals who have been treated within the last 6 months with another stent;
  • •Acute myocardial infarction with ST segment elevation;
  • •Chronic Total Occlusion

Outcomes

Primary Outcomes

MACE (major cardiac events)

Time Frame: 12 months

Major cardiac events (death, myocardial infarction, target vessel revascularization)

Secondary Outcomes

  • Acute success(up to 24 hours)
  • Stent Thrombosis(24 months)
  • MACE(24 months)

Study Sites (2)

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