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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014