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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01296399
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : February 15, 2011
Sponsor:
Information provided by:
Rambam Health Care Campus

Brief 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.


Condition or disease
In-stent Coronary Artery Restenosis

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Group/Cohort
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



Primary Outcome Measures :
  1. The rate of angiographic in-stent restenosis of a stent deployed within de-novo lesions [ Time Frame: one year after the stent was deployed ]

Secondary Outcome Measures :
  1. all cause mortality all cause mortality [ Time Frame: one year after the stent was deployed ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients who underwent percutaneous coronary intervention in Rambam Medical Center between 2000 -2010.
Criteria

Inclusion Criteria:

  • The patient underwent coronary angiography and subsequent angioplasty with deployment of a bare metal stent within de novo stenotic lesion.
  • The patient underwent a second coronary procedure, more then six month from the first procedure, in which patency of the previously deployed bare metal stent was demonstrated, provided that no intervention was performed within this stent in the six month interim. In lieu, either bare metal stent or drug eluting stent were deployed within another stenotic lesion (another de novo lesion).
  • The patient underwent a third coronary angiography procedure within the 12 month interim from the second coronary procedure, in which in-stent restenosis was demonstrated within the stent deployed in the second procedure
  • If no in-stent restenosis was demonstrated within the stent, deployed in the second procedure within the 12 month interim from the second procedure, the patient underwent coronary angiography at least 12 month from the second procedure in which patency of the bare metal stent or drug eluting stent was determined

Exclusion Criteria:

  • Patients in whom a stent, in either the first or second procedure was deployed within previously stent treated stenotic lesion.
  • Patients in whom a stent, in either the first or second procedure, was deployed within a graft.
  • Patient suffering from in-stent restenosis within the bare metal stent, during the six month interim between the first procedure and second procedure or at the time of the second coronary angiography
  • Patients who underwent a coronary intervention within the bare metal stent in interim between the first and second procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296399


Locations
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Israel
Rambam Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Doron Sudarsky, MD Rambam Health Care Campus
Study Chair: Arthur Kerner, MD Rambam Health Care Campus
Publications:

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Responsible Party: Dr. Doron Sudarsky, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT01296399    
Other Study ID Numbers: 02511CTIL
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: February 2011
Keywords provided by Rambam Health Care Campus:
in stent restenosis
bare metal stent
drug eluting stent
de novo lesion
Additional relevant MeSH terms:
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Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases