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

NCT00852176 | Unknown DMC

• 1 other identifier: Best PMA Post-approval Study
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary In-stent Restenosis

Keywords

Coronary brachytherapy; Coronary restenosis; Coronary in stent restenosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients who do not give informed consent

Sponsors & Collaborators

• Best Vascular, Inc.: lead

Study Sites (1)

Washington Hospital Center / Cardiovascular Research Institute (CRI)

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Ron Waksman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Torguson, MPH

CONTACT

202-877-2194; rebecca.torguson@medstar.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2009
• First Posted: February 26, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

US (1)