Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by Best Vascular, Inc..
Recruitment status was Recruiting

Sponsor:

Information provided by:

Best Vascular, Inc.

ClinicalTrials.gov Identifier:

NCT00852176

First received: February 24, 2009

Last updated: March 31, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2009

Last Updated Date

March 31, 2010

Start Date ^ICMJE

May 2009

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Major Adverse Cardiac Events (MACE) [ Time Frame: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00852176 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of device-related procedural events [ Time Frame: At time of intervention ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Target Vessel Revascularization (TVR) [ Time Frame: 6 months; 1, 2, 3, 4, and 5 years post-treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System

Official Title ^ICMJE

Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients treated on-label with the Beta-Cath™ 3.5F System at Washington Hospital Center

Condition ^ICMJE

Coronary In-stent Restenosis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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").

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Rebecca Torguson, MPH

202-877-2194

rebecca.torguson@medstar.net

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00852176

Other Study ID Numbers ^ICMJE

Best PMA Post-approval Study

Has Data Monitoring Committee

Yes

Responsible Party

Wendy Perreault / Regulatory Affairs Consultant, Best Vascular, Inc.

Study Sponsor ^ICMJE

Best Vascular, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ron Waksman, MD

Washington Hospital Center

Information Provided By

Best Vascular, Inc.

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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