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

Coronary In-stent Restenosis Clinical Trial

Official title:

Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00852176
• Other study ID #: Best PMA Post-approval Study
• Status: Recruiting
• Start date: May 2009
• Est. completion date: December 2020

Study information

• Verified date: July 2018
• Source: Best Vascular, Inc.
• Contact: Rebecca Torguson, MPH
• Phone: 202-877-2194
• Email: rebecca.torguson[@]medstar.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary In-stent Restenosis

Locations

Country	Name	City	State
United States	Washington Hospital Center / Cardiovascular Research Institute (CRI)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Best Vascular, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE)	Major Adverse Cardiac Events (MACE)	In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment
Secondary	Incidence of device-related procedural events	Incidence of device-related procedural events	At time of intervention
Secondary	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	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
Secondary	Target Vessel Revascularization (TVR)	Target Vessel Revascularization (TVR)	6 months; 1, 2, 3, 4, and 5 years post-treatment