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

Status unconfirmed

Conditions studied: Coronary In-stent Restenosis

In brief

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.

Key facts

Study ID

NCT00852176

Run by

Best Vascular, Inc.

People needed

200

Starts

2009-05-01

Expected to finish

2020-12-01

Last updated by the study team

2018-07-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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
• 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:
• On or after February 8, 2002 for the 30/40mm 3.5F System
• On or after June 25, 2003 for the 60mm 3.5F System

You may not qualify if…

• Patients who do not give informed consent
• Patients who do not meet the inclusion criteria

Where it is running

• Washington Hospital Center / Cardiovascular Research Institute (CRI) — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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