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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00852176

Enrollment

200

Registered

2009-02-26

Start date

2009-05-31

Completion date

2020-12-31

Last updated

2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary In-stent Restenosis

Keywords

Coronary brachytherapy, Coronary restenosis, Coronary in stent restenosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

United States

Contacts

Primary ContactRebecca Torguson, MPH

rebecca.torguson@medstar.net202-877-2194

Outcome results