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In-stent Restenosis in Patients With Patent Previous Bare Metal Stent

NCT01296399 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2011-02-15

No results posted yet for this study

Summary

Intra-coronary stents deployment reduces the rate of angiographic restenosis as compared to Balloon angioplasty. in-stent restenosis, usually defined as ≥50 percent diameter stenosis within previously deployed stent, is most often becoming clinically evident within the first 6 to 12 months after the stent was deployed. Several risk factors are predictors for the development of in-stent restenosis. These can be generally calcified as either clinical, angiographic or procedural related factors. However it is difficult to estimate to what extent In stent re-stenosis is influenced by these various components.

Drug eluting stent, as compared to bare metal stents, markedly reduced the incidence of angiographic in-stent restenosis. However this benefit must be weighed against a suggested increased risk of late and very late stent thrombosis, a catastrophic event often leading to myocardial infarction and death. Often in patients with existing risk factors for in-stent restenosis, drug eluting stents will be deployed even in cases where patency of a previously deployed bare metal stent have been demonstrated.

Therefore the researchers sought to investigate whether in patients with previously deployed bare metal stent and no evidence of in-stent re-stenosis there will be a significant difference in the rates of in-stent between drug eluting stents and bare metal stents deployed within de-novo stenotic lesions.

Conditions

  • In-stent Coronary Artery Restenosis

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Doron Sudarsky, MD · Rambam Health Care Campus

  • Arthur Kerner, MD · Rambam Health Care Campus

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01296399 on ClinicalTrials.gov