Status:
COMPLETED
SCRIPPS V: Intracoronary Brachytherapy for Recurrent Restenosis After Multiple Drug-Eluting Stents
Lead Sponsor:
Scripps Health
Conditions:
Coronary Artery Disease
Coronary Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is a prospective study of patients treated at Scripps Clinic with intracoronary brachytherapy for recurrent restenosis within drug eluting stents.
Detailed Description
This is an investigator-initiated protocol examining the effectiveness of intracoronary brachytherapy using the Novoste beta-emitting catheter for recurrent stenosis after treatment with multiple drug...
Eligibility Criteria
Inclusion
- Age 18 years or older.
- Eligible for percutaneous coronary intervention.
- Target lesion with recurrent restenosis (\>50% by visual estimate) previously treated with any 2 or more combination of DES stents.
- Signs or symptoms of ischemia attributable to the target lesion, or stenosis \> 50% by visual estimation of the lesion during angiography.
- Target lesion is located within a native coronary artery or bypass graft.
- Be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up.
- Able to understand and sign informed consent.
Exclusion
- Confirmed pregnancy at the time of index PCI.
- Has known allergies to aspirin, and to both clopidogrel (Plavix ®) and ticlopidine (Ticlid ®).
- Has known allergies or contraindication to heparin and Bivalirudin (Angiomax ®).
- Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
- Any serious disease condition with life expectancy of less than 1 year.
- Unsuccessful coronary revascularization procedure (residual stenosis \> 30%).
- Angiographic evidence of thrombus.
- No Previous intracoronary radiation to the target artery.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00714545
Start Date
April 1 2006
End Date
November 1 2013
Last Update
October 22 2020
Active Locations (1)
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1
Scripps Green Hospital/Scripps Clinic
La Jolla, California, United States, 92037