Recruiting

Beta-Cath

Sponsor:

Best Vascular, Inc.

Code:

NCT00852176

Conditions

Coronary In-stent Restenosis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Coronary In-stent Restenosis

Study ID

NCT00852176

Start date

May, 2009

Status verified date

Jul, 2018

Completion date

Dec, 2020

Anticipated

Primary completion date

May, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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").

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Rebecca Torguson, MPH

202-877-2194rebecca.torguson@medstar.net

Locations

Washington Hospital Center / Cardiovascular Research Institute (CRI)

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Rebecca Torguson, MPH

202-877-2194rebecca.torguson@medstar.net

Principal Investigator:

Ron Waksman, MD

More Information

Sponsor

Best Vascular, Inc.

Last update posted

Jul 11, 2018

Last verified

Jul, 2018

Keywords

  • Coronary brachytherapy
  • Coronary restenosis
  • Coronary in stent restenosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Best Vascular, Inc. on 2018-07-11.