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

Best Vascular

Status: Unknown

Conditions: Coronary In-stent Restenosis

Study type: Observational

Funder types: Industry

Identifiers

NCT00852176

Best PMA Post-approval Study

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

On-label treatment

Description:

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").