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

Sponsor

Scripps Health (Other)

Overall Status

Completed

CT.gov ID

NCT00714545

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Restenosis	Radiation: Intracoronary brachytherapy	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.	Radiation: Intracoronary brachytherapy Beta irradiation with a 40-mm strontium/lytrium-90 source

Arm

Intervention/Treatment

No Intervention: 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.

Radiation: Intracoronary brachytherapy

Beta irradiation with a 40-mm strontium/lytrium-90 source

Outcome Measures

Primary Outcome Measures

To determine the safety and efficacy of intracoronary brachytherapy for the treatment of recurrent restenosis within drug-eluting stents. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.