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
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington Hospital Center / Cardiovascular Research Institute (CRI) | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Best Vascular, Inc. |
United States,
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 |
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