Washington, District of Columbia 20010

  • stent Restenosis

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.


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


NCT ID:

NCT00852176


Primary Contact:

Principal Investigator
Ron Waksman, MD
Washington Hospital Center

Rebecca Torguson, MPH
Phone: 202-877-2194
Email: rebecca.torguson@medstar.net


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20010
United States

Rebecca Torguson, MPH
Phone: 202-877-2194
Email: rebecca.torguson@medstar.net

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 27, 2022

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.