Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Best Vascular, Inc..
Recruitment status was Recruiting
Information provided by:
Best Vascular, Inc.
First received: February 24, 2009
Last updated: March 31, 2010
Last verified: March 2010
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.
Coronary In-stent Restenosis
||Observational Model: Cohort
Time Perspective: Retrospective
||Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
Primary Outcome Measures:
- Major Adverse Cardiac Events (MACE) [ Time Frame: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of device-related procedural events [ Time Frame: At time of intervention ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Target Vessel Revascularization (TVR) [ Time Frame: 6 months; 1, 2, 3, 4, and 5 years post-treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
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").
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients treated on-label with the Beta-Cath™ 3.5F System at Washington Hospital Center
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
- Patients who do not give informed consent
- Patients who do not meet the inclusion criteria
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852176
|Washington Hospital Center / Cardiovascular Research Institute (CRI)
|Washington, District of Columbia, United States, 20010 |
|Contact: Rebecca Torguson, MPH 202-877-2194 firstname.lastname@example.org |
|Principal Investigator: Ron Waksman, MD |
|Sub-Investigator: Lowell Satler, MD |
|Sub-Investigator: Kenneth Kent, MD |
|Sub-Investigator: William Suddath, MD |
Best Vascular, Inc.
||Ron Waksman, MD
||Washington Hospital Center
No publications provided
||Wendy Perreault / Regulatory Affairs Consultant, Best Vascular, Inc.
History of Changes
|Other Study ID Numbers:
||Best PMA Post-approval Study
|Study First Received:
||February 24, 2009
||March 31, 2010
||United States: Institutional Review Board
Keywords provided by Best Vascular, Inc.:
ClinicalTrials.gov processed this record on April 15, 2014
Coronary in stent restenosis