Coronary Artery DiseasePhase 4NCT00714545
SCRIPPS V: Intracoronary Brachytherapy for Recurrent Restenosis After Multiple Drug-Eluting Stents
A Phase 4 study testing Intracoronary brachytherapy in people with Coronary Artery Disease and Coronary Restenosis, run by Scripps Health at 1 site in United States.
Trial summary
This study is a prospective study of patients treated at Scripps Clinic with intracoronary brachytherapy for recurrent restenosis within drug eluting stents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- Intracoronary brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Green Hospital/Scripps Clinic
La Jolla, California, 92037
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Coronary Restenosis
- Being tested
- Intracoronary brachytherapy
- Keywords
- Coronary Artery Disease, Coronary Restenosis, Brachytherapy
- Medical subject headings
- Coronary Artery Disease, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary brachytherapyRadiation
Beta irradiation with a 40-mm strontium/lytrium-90 source
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Intracoronary brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and efficacy of intracoronary brachytherapy for the treatment of recurrent restenosis within drug-eluting stents.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startApr 2006
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul S Teirstein, MD, Scripps Health
- Investigators
- Paul S. Teirstein, MD, Principal investigator, Scripps Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714545
- Sponsor's protocol ID
- 004408
- Status last verified
- Oct 2020
- First submitted
- 9 Jul 2008
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Brachytherapy for Recurrent Restenosis After Multiple Drug-Eluting Stents. Short Title: Scripps V
- ClinicalTrials.gov ID
- NCT00714545
- Acronym / sponsor ID
- 004408
- Conditions
- Coronary Artery Disease, Coronary Restenosis
- Keywords
- Coronary Artery Disease, Coronary Restenosis, Brachytherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prospective study | No intervention | Radiation: Intracoronary brachytherapyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracoronary brachytherapyBeta irradiation with a 40-mm strontium/lytrium-90 source | Radiation | prospective study |
Primary outcome
To determine the safety and efficacy of intracoronary brachytherapy for the treatment of recurrent restenosis within drug-eluting stents.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul S. Teirstein, MD principal investigator
Scripps Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intracoronary brachytherapy in people with Coronary Artery Disease and Coronary Restenosis, run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety and efficacy of intracoronary brachytherapy for the treatment of recurrent restenosis within drug-eluting stents. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.