- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00852176
Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
July 9, 2018 updated by: Best Vascular, Inc.
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
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
-
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Recruiting
- Washington Hospital Center / Cardiovascular Research Institute (CRI)
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Contact:
- Rebecca Torguson, MPH
- Phone Number: 202-877-2194
- Email: rebecca.torguson@medstar.net
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Sub-Investigator:
- Lowell Satler, MD
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Sub-Investigator:
- Kenneth Kent, MD
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Sub-Investigator:
- William Suddath, MD
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients treated on-label with the Beta-Cath™ 3.5F System at Washington Hospital Center
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Patients who do not give informed consent
- Patients who do not meet the inclusion criteria
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
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Adverse Cardiac Events (MACE)
Time Frame: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment
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Major Adverse Cardiac Events (MACE)
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In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of device-related procedural events
Time Frame: At time of intervention
|
Incidence of device-related procedural events
|
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
|
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
|
At time of intervention
|
Target Vessel Revascularization (TVR)
Time Frame: 6 months; 1, 2, 3, 4, and 5 years post-treatment
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Target Vessel Revascularization (TVR)
|
6 months; 1, 2, 3, 4, and 5 years post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ron Waksman, MD, MedStar Health Research Institute
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
May 1, 2009
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
February 24, 2009
First Submitted That Met QC Criteria
February 25, 2009
First Posted (Estimate)
February 26, 2009
Study Record Updates
Last Update Posted (Actual)
July 11, 2018
Last Update Submitted That Met QC Criteria
July 9, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Best PMA Post-approval Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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