Trials / Unknown
UnknownNCT00852176
Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Best Vascular, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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 approval of the System. Outcomes will be reported up to 5 years following treatment.
Conditions
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2020-05-01
- Completion
- 2020-12-01
- First posted
- 2009-02-26
- Last updated
- 2018-07-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00852176. Inclusion in this directory is not an endorsement.