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

• Conditions: Coronary In-stent Restenosis

• Registration Number: NCT00852176
• Lead Sponsor: Best Vascular, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-25
• Study First Posted: 2009-02-26
• Study Start: 2009-05
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-11
• Primary Completion: 2020-05
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)	In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment	Major Adverse Cardiac Events (MACE)

Secondary Outcome Measures

Name	Time	Method
Incidence of device-related procedural events	At time of intervention	Incidence of device-related procedural events
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	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
Target Vessel Revascularization (TVR)	6 months; 1, 2, 3, 4, and 5 years post-treatment	Target Vessel Revascularization (TVR)

Trial Locations

Locations (1)

Washington Hospital Center / Cardiovascular Research Institute (CRI); 🇺🇸 Washington, District of Columbia, United States