SCRIPPS V: Intracoronary Brachytherapy for Recurrent Restenosis After Multiple Drug-Eluting Stents

Completed · Phase 4

Conditions studied: Coronary Artery Disease, Coronary Restenosis

In brief

This study is a prospective study of patients treated at Scripps Clinic with intracoronary brachytherapy for recurrent restenosis within drug eluting stents.

Key facts

Study ID

NCT00714545

Run by

Scripps Health

People needed

65

Starts

2006-04-01

Expected to finish

2013-11-01

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Scripps Green Hospital/Scripps Clinic — La Jolla, California, United States

Full record on ClinicalTrials.gov

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