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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
History of Changes
  Purpose

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.


Condition
Coronary In-stent Restenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System

Further study details as provided by Best Vascular, Inc.:

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: 200
Study Start Date: May 2009
Groups/Cohorts
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").

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852176

Contacts
Contact: Rebecca Torguson, MPH 202-877-2194 rebecca.torguson@medstar.net

Locations
United States, District of Columbia
Washington Hospital Center / Cardiovascular Research Institute (CRI) Recruiting
Washington, District of Columbia, United States, 20010
Contact: Rebecca Torguson, MPH     202-877-2194     rebecca.torguson@medstar.net    
Principal Investigator: Ron Waksman, MD            
Sub-Investigator: Lowell Satler, MD            
Sub-Investigator: Kenneth Kent, MD            
Sub-Investigator: William Suddath, MD            
Sponsors and Collaborators
Best Vascular, Inc.
Investigators
Principal Investigator: Ron Waksman, MD Washington Hospital Center
  More Information

No publications provided

Responsible Party: Wendy Perreault / Regulatory Affairs Consultant, Best Vascular, Inc.
ClinicalTrials.gov Identifier: NCT00852176     History of Changes
Other Study ID Numbers: Best PMA Post-approval Study
Study First Received: February 24, 2009
Last Updated: March 31, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Best Vascular, Inc.:
Coronary brachytherapy
Coronary restenosis
Coronary in stent restenosis

ClinicalTrials.gov processed this record on May 21, 2013