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

Primary Purpose

Coronary Artery Disease, Coronary Restenosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Intracoronary brachytherapy

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Coronary Restenosis, Brachytherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Scripps Green Hospital/Scripps Clinic

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

prospective study

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00714545

First Posted

July 9, 2008

Last Updated

October 19, 2020

Sponsor

Scripps Health

1. Study Identification

Unique Protocol Identification Number

NCT00714545

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Scripps Health

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Coronary Restenosis

Keywords

Coronary Artery Disease, Coronary Restenosis, Brachytherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

prospective study

Arm Type

No Intervention

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Intracoronary brachytherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul S. Teirstein, MD

Organizational Affiliation

Scripps Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Scripps Green Hospital/Scripps Clinic

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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