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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary In-stent Restenosis

Participation Criteria
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Eligibility Criteria
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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. 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 Exclusion Criteria: Patients who do not give informed consent Patients who do not meet the inclusion criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| On-label treatment<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device-related procedural events | Incidence of device-related procedural events | 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 | 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 | 
| Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) | 6 months; 1, 2, 3, 4, and 5 years post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary brachytherapy, Coronary restenosis, Coronary in stent restenosis