In-stent Restenosis in Patients With Patent Previous Bare Metal Stent
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|ClinicalTrials.gov Identifier: NCT01296399|
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : February 15, 2011
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.
|Condition or disease|
|In-stent Coronary Artery Restenosis|
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||The Rate of In-stent Restenosis Within Bare Metal Stents as Compared to Drug Eluting Stents in Patients With Patent Previously Deployed Bare Metal Stent|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Bare metal stent
patients, with a patent previously deployed intra coronary bare metal stent, receiving intra coronary bare metal stent, for de-novo stenosis
Drug eluting stent
patients, with a patent previously deployed intra coronary bare metal stent, receiving intra coronary drug eluting stent, for de-novo stenosis
- The rate of angiographic in-stent restenosis of a stent deployed within de-novo lesions [ Time Frame: one year after the stent was deployed ]
- all cause mortality all cause mortality [ Time Frame: one year after the stent was deployed ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296399
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Principal Investigator:||Doron Sudarsky, MD||Rambam Health Care Campus|
|Study Chair:||Arthur Kerner, MD||Rambam Health Care Campus|