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

October 19, 2020 updated by: Paul S Teirstein, MD, Scripps Health

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital/Scripps Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the safety and efficacy of intracoronary brachytherapy for the treatment of recurrent restenosis within drug-eluting stents.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (ESTIMATE)

July 14, 2008

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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