Safety and Efficacy Study Comparing Thrombin for Arterial Sealing

NCT00388284 | Completed Phase 3

• 1 other identifier: 0106
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 6

Brief Summary

This trial is designed as a prospective, multi-center, randomized, double blinded clinical trial to evaluate the safety and efficacy of the Thrombin VSI. An immunological sub-study to assess antibody and coagulation changes in the subjects following exposure to the Vascular Solutions Diagnostic Duett Pro manufactured with Thrombin VSI and Thrombin JMI will be conducted as a component of this trial with a subset of the enrolled study subjects. Two hundred seventy (270) subjects will be enrolled in this trial. A minimum of 50% of the subjects will be interventional subjects and up to 50% will be diagnostic subjects. All 270 subjects will provide blood specimens at baseline and at the 30 day follow-up visit for evaluation in the immunologic sub-study. Within the 270 subjects enrolled, a minimum of 45 subjects treated with the Thrombin VSI and a minimum of 45 subjects treated with the Thrombin JMI will provide blood specimens at the 60 day follow-up visit to be evaluated in the immunologic sub-study. The primary efficacy objective is to demonstrate that the device time-to-hemostasis for the study group treated with the sealing device manufactured with Thrombin VSI is non-inferior to the study group treated with the sealing device manufactured with Thrombin JMI. The primary safety objective is to demonstrate a device-related major complication rate for the study group treated with the sealing device manufactured with Thrombin VSI that is non-inferior to the device-related major complication rate observed for the study group treated with the sealing device manufactured with Thrombin JMI.

Conditions

Hemostasis of Arterial Punctures

Keywords

hemostasis; arterial sealing

Outcome Measures

Primary Outcomes (2)

• Time to Hemostasis

• Incidence rate of device-related major complications

Secondary Outcomes (5)

• Time to ambulation

• Subject satisfaction

• Procedure success

• Device success

• Minor complications

Interventions

Arterial Sealing DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is 18 years of age or older
• The subject is undergoing a diagnostic or interventional endovascular procedure via a retrograde femoral arterial access
• The subject is willing and able to provide appropriate informed consent
• The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations

You may not qualify if:

• The subject has a history of clinically severe peripheral vascular disease documented as any of the following:
• Severe claudication (walking \< 100 feet)
• Absent pulses in the affected limb
• ABI \< 0.5 at rest
• Known diameter stenosis ≥ 50% in the iliac or femoral artery on the affected side
• Prior vascular bypass surgery involving the affected femoral artery
• Prior stent placement in the vicinity of the arterial puncture site
• The subject is known to be, or suspected to be, pregnant (verified in a manner consistent with institution's standard of care), or is lactating
• The subject has a pre-existing severe non-cardiac systemic disease or pre-existing terminal illness
• The subject has had an acute myocardial infarction ≤ 72 hours before the catheterization procedure
• The subject is unable to ambulate at baseline
• The subject is known to require an extended hospitalization (e.g., subject is undergoing CABG surgery)
• The subject has a known bleeding disorder (including thrombocytopenia \[\< 100,000 platelet count\], thrombobasthenia, hemophilia, or von Willebrand disease)
• The subject is receiving Coumadin/warfarin therapy and has an INR \> 2.0 on the day of, or the day before the study procedure. (INR of \> 2.0 should not result in a dose change prior to the study procedure. If dosage changed, test should be repeated prior to the procedure)
• The subject has a known allergy to bovine derived products or any other materials used in the Diagnostic Duett Pro Sealing Device

Sponsors & Collaborators

• Vascular Solutions LLC: lead

Study Sites (6)

The Heart and Vascualr Institute of Florida

Safety Harbor, Florida, 34695, United States

Location

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

WakeMed

Raleigh, North Carolina, 27610, United States

Location

Mary Washington Hospital

Fredericksburg, Virginia, 22401, United States

Location

Charleston Area Medica Center (CAMC)

Charleston, West Virginia, 25304, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 11, 2006
• First Posted: October 16, 2006
• Study Start: August 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: December 9, 2015

Record last verified: 2008-02

Locations

US (6)