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

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01296399
First received: February 13, 2011
Last updated: February 14, 2011
Last verified: February 2011
History of Changes
  Purpose

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
In-stent Coronary Artery Restenosis

Study Type: Observational
Study Design: 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

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • The rate of angiographic in-stent restenosis of a stent deployed within de-novo lesions [ Time Frame: one year after the stent was deployed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • all cause mortality all cause mortality [ Time Frame: one year after the stent was deployed ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: January 2000
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296399

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

Publications:

Responsible Party: Dr. Doron Sudarsky, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT01296399     History of Changes
Other Study ID Numbers: 02511CTIL
Study First Received: February 13, 2011
Last Updated: February 14, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
in stent restenosis
bare metal stent
drug eluting stent
de novo lesion

Additional relevant MeSH terms:
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013