Status:
UNKNOWN
Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
Lead Sponsor:
Best Vascular, Inc.
Conditions:
Coronary In-stent Restenosis
Eligibility:
All Genders
Brief 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 retr...
Eligibility Criteria
Inclusion
- 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
- Patients who do not give informed consent
- Patients who do not meet the inclusion criteria
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00852176
Start Date
May 1 2009
End Date
December 1 2020
Last Update
July 11 2018
Active Locations (1)
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1
Washington Hospital Center / Cardiovascular Research Institute (CRI)
Washington D.C., District of Columbia, United States, 20010