NCT00714545

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

Intracoronary Brachytherapy for Recurrent Restenosis After Multiple Drug-Eluting Stents. Short Title: Scripps V

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Scripps Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-eluting stents. While intracoronary brachytherapy has been used for this purpose by clinicians for some time, data supporting this clinical decision-making is lacking. 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

• Coronary Artery Disease
• Coronary Restenosis

Interventions

Type	Name	Description
RADIATION	Intracoronary brachytherapy	Beta irradiation with a 40-mm strontium/lytrium-90 source

Timeline

• Start date: 2006-04-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2008-07-14
• Last updated: 2020-10-22

Locations

1 site across 1 country: United States