Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00852176 |
Recruitment Status
:
Recruiting
First Posted
: February 26, 2009
Last Update Posted
: February 8, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Coronary In-stent Restenosis |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
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 |
Study Start Date : | May 2009 |
Estimated Primary Completion Date : | May 2020 |
Estimated Study Completion Date : | December 2020 |
Group/Cohort |
---|
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").
|
- 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 [ 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852176
Contact: Rebecca Torguson, MPH | 202-877-2194 | rebecca.torguson@medstar.net |
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 |
Principal Investigator: | Ron Waksman, MD | Washington Hospital Center |
Responsible Party: | Best Vascular, Inc. |
ClinicalTrials.gov Identifier: | NCT00852176 History of Changes |
Other Study ID Numbers: |
Best PMA Post-approval Study |
First Posted: | February 26, 2009 Key Record Dates |
Last Update Posted: | February 8, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Best Vascular, Inc.:
Coronary brachytherapy Coronary restenosis Coronary in stent restenosis |