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

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ClinicalTrials.gov Identifier: NCT00852176
Recruitment Status : Recruiting
First Posted : February 26, 2009
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Best Vascular, Inc.

Study Description
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Brief Summary:
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 or disease
Coronary In-stent Restenosis

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
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
Study Start Date : May 2009
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020
Groups and Cohorts
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Group/Cohort
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").


Outcome Measures
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Primary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE) [ Time Frame: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment ]

Secondary Outcome Measures :
  1. Incidence of device-related procedural events [ Time Frame: At time of intervention ]
  2. 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 ]
  3. Target Vessel Revascularization (TVR) [ Time Frame: 6 months; 1, 2, 3, 4, and 5 years post-treatment ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Best Vascular, Inc.
ClinicalTrials.gov Identifier: NCT00852176     History of Changes
Other Study ID Numbers: Best PMA Post-approval Study
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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