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

NCT01296399 | Completed

• 1 other identifier: 02511CTIL
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

In-stent Coronary Artery Restenosis

Keywords

in stent restenosis; bare metal stent; drug eluting stent; de novo lesion

Outcome Measures

Primary Outcomes (1)

• The rate of angiographic in-stent restenosis of a stent deployed within de-novo lesions

  one year after the stent was deployed

Secondary Outcomes (1)

• all cause mortality all cause mortality

  one year after the stent was deployed

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients who underwent percutaneous coronary intervention in Rambam Medical Center between 2000 -2010.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, 31096, Israel

Location

Related Publications (32)

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Study Officials

• Doron Sudarsky, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

• Arthur Kerner, MD

  Rambam Health Care Campus

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2011
• First Posted: February 15, 2011
• Study Start: January 1, 2000
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 15, 2011

Record last verified: 2011-02

Locations

IL (1)