SCRIPPS V: Intracoronary Brachytherapy for Recurrent Restenosis After Multiple Drug-Eluting Stents
NCT ID: NCT00714545
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
65 participants
INTERVENTIONAL
2006-04-30
2013-11-30
Brief Summary
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Detailed Description
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Currently, when cardiologists find restenosis after implanting a drug-eluting stent, they often place a stent that elutes a different drug within that stent. If a patient presents with restenosis in the segment that has already been treated with both sirolimus and paclitaxel-eluting stents, further options are limited. Intracoronary brachytherapy is often used in this scenario, but the efficacy of this approach has not been well studied. The investigators recently reviewed the clinical outcomes of five patients who underwent intracoronary radiation after drug-eluting stents. They discovered only one episode of target vessel revascularization and no episodes of stent thrombosis. While this sample is small, investigators believe that a prospective study will provide important information regarding this approach.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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prospective study
This study is a prospective study of patients treated at Scripps Clinic with intracoronary brachytherapy for recurrent restenosis within drug-eluting stents. Beta irradiation with a 40-mm strontium/yttrium-90 source. No placebo will be used in this trial.
Intracoronary brachytherapy
Beta irradiation with a 40-mm strontium/lytrium-90 source
Interventions
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Intracoronary brachytherapy
Beta irradiation with a 40-mm strontium/lytrium-90 source
Eligibility Criteria
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Inclusion Criteria
2. Eligible for percutaneous coronary intervention.
3. Target lesion with recurrent restenosis (\>50% by visual estimate) previously treated with any 2 or more combination of DES stents.
4. Signs or symptoms of ischemia attributable to the target lesion, or stenosis \> 50% by visual estimation of the lesion during angiography.
5. Target lesion is located within a native coronary artery or bypass graft.
6. Be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up.
7. Able to understand and sign informed consent.
Exclusion Criteria
2. Has known allergies to aspirin, and to both clopidogrel (Plavix ®) and ticlopidine (Ticlid ®).
3. Has known allergies or contraindication to heparin and Bivalirudin (Angiomax ®).
4. Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
5. Any serious disease condition with life expectancy of less than 1 year.
6. Unsuccessful coronary revascularization procedure (residual stenosis \> 30%).
7. Angiographic evidence of thrombus.
8. No Previous intracoronary radiation to the target artery.
18 Years
ALL
No
Sponsors
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Scripps Health
OTHER
Responsible Party
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Paul S Teirstein, MD
Director, Scripps Cardiovascular Institute
Principal Investigators
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Paul S. Teirstein, MD
Role: PRINCIPAL_INVESTIGATOR
Scripps Clinic
Locations
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Scripps Green Hospital/Scripps Clinic
La Jolla, California, United States
Countries
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Other Identifiers
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004408
Identifier Type: -
Identifier Source: org_study_id
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