Coronary In-stent RestenosisNCT00852176
Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
An observational study of Coronary In-stent Restenosis, run by Best Vascular, Inc. at 1 site in United States.
Trial summary
The study will evaluate the long-term safety and efficacy of intravascular beta radiation therapy to treat coronary in-stent restenosis using the Beta-Cath(TM) 3.5F System; data will be collected retrospectively on patients treated with the Beta-Cath™ 3.5F System in routine clinical practice following FDA pre-market… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary In-stent Restenosis
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated on-label with the Beta-Cath™ 3.5F System at Washington Hospital Center
Who may be able to join
- Patients who underwent on-label treatment (as defined below) with the Beta-Cath™ 3.5F System (30, 40 or 60mm) for in-stent restenosis (ISR) after coronary stenting.
- On-label treatment for the 30 and 40mm Beta-Cath™ 3.5F System is defined as: treatment of ISR in native coronary arteries with discrete lesions (treatable with a 20mm balloon) in reference vessel diameters (RVD) ranging from 2.7mm to 4.0mm
- On-label treatment for the 60mm Beta-Cath™ 3.5F System is defined as: treatment of ISR in native coronary arteries with lesions <40mm in length in RVD ranging from 2.7mm to 4.0mm
- Patients must have undergone brachytherapy treatment at least 6-8 months prior to enrollment in this retrospective study and the date of their treatment must be:
- On or after February 8, 2002 for the 30/40mm 3.5F System
- On or after June 25, 2003 for the 60mm 3.5F System
Who cannot join
- Patients who do not give informed consent
- Patients who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington Hospital Center / Cardiovascular Research Institute (CRI)
Washington D.C., District of Columbia, 20010
Rebecca Torguson, MPH, 202-877-2194, rebecca.torguson@medstar.net
Ron Waksman, MD
About this study
Official title: Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
The study will evaluate the long-term safety and efficacy of intravascular beta radiation therapy to treat coronary in-stent restenosis using the Beta-Cath(TM) 3.5F System; data will be collected retrospectively on patients treated with the Beta-Cath™ 3.5F System in routine clinical practice following FDA pre-market approval of the System. Outcomes will be reported up to 5 years following treatment.
- Conditions
- Coronary In-stent Restenosis
- Keywords
- Coronary brachytherapy, Coronary restenosis, Coronary in stent restenosis
- Medical subject headings
- Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| On-label treatment | Patients treated in routine clinical practice following FDA Pre-Market Approval of the Beta-Cath(TM) 3.5F System within the parameters of the approved indications for use for the System ("on-label"). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE)
Measured: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment
Secondary outcomes (3)
Incidence of device-related procedural events
Incidence of device-related procedural events
Measured: At time of intervention
Device success, including successful delivery of the Beta-Cath(TM) 3.5F System radiation source train, return of the radiation source train, and delivery of the intended dose
Device success, including successful delivery of the Beta-Cath(TM) 3.5F System radiation source train, return of the radiation source train, and delivery of the intended dose
Measured: At time of intervention
Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR)
Measured: 6 months; 1, 2, 3, 4, and 5 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary In-stent RestenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Best Vascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852176
- Sponsor's protocol ID
- Best PMA Post-approval Study
- Status last verified
- Jul 2018
- First submitted
- 24 Feb 2009
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
- ClinicalTrials.gov ID
- NCT00852176
- Acronym / sponsor ID
- Best PMA Post-approval Study
- Conditions
- Coronary In-stent Restenosis
- Keywords
- Coronary brachytherapy, Coronary restenosis, Coronary in stent restenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Best Vascular, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Feb 2009 (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.
The study will evaluate the long-term safety and efficacy of intravascular beta radiation therapy to treat coronary in-stent restenosis using the Beta-Cath(TM) 3.5F System; data will be collected retrospectively on patients treated with the Beta-Cath™ 3.5F System in routine clinical practice following FDA pre-market approval of the System. Outcomes will be reported up to 5 years following treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| On-label treatment | – | –Patients treated in routine clinical practice following FDA Pre-Market Approval of the Beta-Cath(TM) 3.5F System within the parameters of the approved indications for use for the System ("on-label"). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated on-label with the Beta-Cath™ 3.5F System at Washington Hospital Center
Key inclusion criteria (6 listed)
- Patients who underwent on-label treatment (as defined below) with the Beta-Cath™ 3.5F System (30, 40 or 60mm) for in-stent restenosis (ISR) after coronary stenting.
- Patients must have undergone brachytherapy treatment at least 6-8 months prior to enrollment in this retrospective study and the date of their treatment must be:
Key exclusion criteria (2 listed)
- Patients who do not give informed consent
- Patients who do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiac Events (MACE)
Time frame: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment
Major Adverse Cardiac Events (MACE)
3 secondary outcomes
Incidence of device-related procedural events
Time frame: At time of intervention
Device success, including successful delivery of the Beta-Cath(TM) 3.5F System radiation source train, return of the radiation source train, and delivery of the intended dose
Time frame: At time of intervention
Target Vessel Revascularization (TVR)
Time frame: 6 months; 1, 2, 3, 4, and 5 years post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Ron Waksman, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary In-stent Restenosis, run by Best Vascular, Inc. 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Jul 2018. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Torguson, MPH (202-877-2194, rebecca.torguson@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) (time frame: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment). 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 11 Jul 2018.