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Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
This study is currently recruiting participants.
Verified February 2017 by Best Vascular, Inc.
Sponsor:
Best Vascular, Inc.
Information provided by (Responsible Party):
Best Vascular, Inc.
ClinicalTrials.gov Identifier:
NCT00852176
First received: February 24, 2009
Last updated: February 6, 2017
Last verified: February 2017
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Purpose
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.
| Condition |
|---|
| Coronary In-stent Restenosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System |
Further study details as provided by Best Vascular, Inc.:
Primary Outcome Measures:
- Major Adverse Cardiac Events (MACE) [ Time Frame: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment ]
Secondary Outcome Measures:
- 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 [ Time Frame: At time of intervention ]
- Target Vessel Revascularization (TVR) [ Time Frame: 6 months; 1, 2, 3, 4, and 5 years post-treatment ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | May 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
On-label 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").
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients treated on-label with the Beta-Cath™ 3.5F System at Washington Hospital Center
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852176
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852176
Contacts
| Contact: Rebecca Torguson, MPH | 202-877-2194 | rebecca.torguson@medstar.net |
Locations
| United States, District of Columbia | |
| Washington Hospital Center / Cardiovascular Research Institute (CRI) | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Rebecca Torguson, MPH 202-877-2194 rebecca.torguson@medstar.net | |
| Principal Investigator: Ron Waksman, MD | |
| Sub-Investigator: Lowell Satler, MD | |
| Sub-Investigator: Kenneth Kent, MD | |
| Sub-Investigator: William Suddath, MD | |
Sponsors and Collaborators
Best Vascular, Inc.
Investigators
| Principal Investigator: | Ron Waksman, MD | Washington Hospital Center |
More Information
| Responsible Party: | Best Vascular, Inc. |
| ClinicalTrials.gov Identifier: | NCT00852176 History of Changes |
| Other Study ID Numbers: |
Best PMA Post-approval Study |
| Study First Received: | February 24, 2009 |
| Last Updated: | February 6, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | Undecided |
Keywords provided by Best Vascular, Inc.:
|
Coronary brachytherapy Coronary restenosis Coronary in stent restenosis |
ClinicalTrials.gov processed this record on June 23, 2017