Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/13/2018 |
| Start Date: | May 2009 |
| End Date: | December 2020 |
| Contact: | Rebecca Torguson, MPH |
| Email: | rebecca.torguson@medstar.net |
| Phone: | 202-877-2194 |
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.
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.
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.
1. 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
2. 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:
1. On or after February 8, 2002 for the 30/40mm 3.5F System
2. 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
We found this trial at
1
site
Washington, District of Columbia 20010
Principal Investigator: Ron Waksman, MD
Phone: 202-877-2194
Click here to add this to my saved trials
