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Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Best Vascular, Inc.
Sponsor:
Information provided by (Responsible Party):
Best Vascular, Inc.
ClinicalTrials.gov Identifier:
NCT00852176
First received: February 24, 2009
Last updated: February 6, 2017
Last verified: February 2017

February 24, 2009
February 6, 2017
May 2009
May 2020   (Final data collection date for primary outcome measure)
Major Adverse Cardiac Events (MACE) [ Time Frame: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment ]
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 ]
  • 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 ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 6 months; 1, 2, 3, 4, and 5 years post-treatment ]
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
December 2020
May 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Rebecca Torguson, MPH 202-877-2194 rebecca.torguson@medstar.net
United States
 
 
NCT00852176
Best PMA Post-approval Study
Yes
Not Provided
Undecided
Not Provided
Best Vascular, Inc.
Best Vascular, Inc.
Not Provided
Principal Investigator: Ron Waksman, MD Washington Hospital Center
Best Vascular, Inc.
February 2017

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