Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
Sponsor study identifier
observational
200
1 country
1
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2009
Actual (reported)February 26, 2009
Actual (reported)May 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
At time of intervention
Target Vessel Revascularization (TVR)
6 months; 1, 2, 3, 4, and 5 years post-treatment
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").
Patients treated on-label with the Beta-Cath™ 3.5F System at Washington Hospital Center
Washington Hospital Center / Cardiovascular Research Institute (CRI)
Washington D.C., District of Columbia, 20010, United States
Ron Waksman, MD
Medstar Health Research Institute
First Submitted
February 24, 2009
First Posted
February 26, 2009
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2020
Estimated (date passed)Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 11, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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