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
Sponsor:
Information provided by:
Best Vascular, Inc.
ClinicalTrials.gov Identifier:
NCT00852176
First received: February 24, 2009
Last updated: March 31, 2010
Last verified: March 2010

February 24, 2009
March 31, 2010
May 2009
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00852176 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Patients treated on-label with the Beta-Cath™ 3.5F System at Washington Hospital Center

Coronary In-stent Restenosis
Not Provided
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").
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
Not Provided

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
Both
Not Provided
No
Contact: Rebecca Torguson, MPH 202-877-2194 rebecca.torguson@medstar.net
United States
 
NCT00852176
Best PMA Post-approval Study
Yes
Wendy Perreault / Regulatory Affairs Consultant, Best Vascular, Inc.
Best Vascular, Inc.
Not Provided
Principal Investigator: Ron Waksman, MD Washington Hospital Center
Best Vascular, Inc.
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP