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.
Study Type
OBSERVATIONAL
Enrollment
200
Washington Hospital Center / Cardiovascular Research Institute (CRI)
Washington D.C., District of Columbia, United States
RECRUITINGMajor Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE)
Time frame: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment
Incidence of device-related procedural events
Incidence of device-related procedural events
Time frame: 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
Time frame: At time of intervention
Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR)
Time frame: 6 months; 1, 2, 3, 4, and 5 years post-treatment
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