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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714545
• Other study ID #: 004408
• Status: Completed
• Phase: Phase 4
• Start date: April 2006
• Est. completion date: November 2013

Study information

• Verified date: October 2020
• Source: Scripps Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older.

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:

1. Confirmed pregnancy at the time of index PCI.

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Radiation:
• Intracoronary brachytherapy
Beta irradiation with a 40-mm strontium/lytrium-90 source

Locations

Country	Name	City	State
United States	Scripps Green Hospital/Scripps Clinic	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and efficacy of intracoronary brachytherapy for the treatment of recurrent restenosis within drug-eluting stents.		2 years