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

NCT00714545 | Completed Phase 4 DMC

• 1 other identifier: 004408
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease; Coronary Restenosis

Keywords

Coronary Artery Disease; Coronary Restenosis; Brachytherapy

Outcome Measures

Primary Outcomes (1)

• To determine the safety and efficacy of intracoronary brachytherapy for the treatment of recurrent restenosis within drug-eluting stents.

  2 years

Study Arms (1)

prospective study

NO INTERVENTION

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

Interventions

Intracoronary brachytherapy RADIATION

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

prospective study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (1)

Scripps Green Hospital/Scripps Clinic

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Study Officials

• Paul S. Teirstein, MD

  Scripps Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Scripps Cardiovascular Institute

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 14, 2008
• Study Start: April 1, 2006
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

US (1)