Study to Evaluate Safety & Effectiveness of Vascular Sealant System
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Purpose
To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Vascular Disease |
Device: Gelfoam/Thrombin Device: VascuSeal |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Randomized Study to Evaluate Safety & Effectiveness of Vascular Sealant to Control Suture Line Bleeding |
- The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment. [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]
- The proportion of immediate sealing successes at treated anastomoses by treatment group, with immediate sealing success defined as a site with no suture line bleeding after blood flow is restored [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]
- The proportion of overall sealing successes (within 10 minutes) at treated anastomoses in each treatment group. [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]
- At each site, time to hemostasis was determined from the time circulation was restored after treatment application until bleeding had stopped (assessed at intervals of 1, 3, 5, 7.5 and 10 minutes). [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]
- Time to wound closure was determined, with wound closure defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure. [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]
| Enrollment: | 69 |
| Study Start Date: | April 2007 |
| Study Completion Date: | May 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: VascuSeal
Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
|
Device: VascuSeal
VascuSeal
|
|
Active Comparator: GELFOAM/THROMBIN
GELFOAM/THROMBIN
|
Device: Gelfoam/Thrombin
Gelfoam/Thrombin
|
Detailed Description:
Vascular surgery encompasses a wide range of surgical procedures. In these procedures reduction of blood loss and creation of suture line is of utmost importance to the surgeon. Bleeding at the suture line may require transfusion, as well as prolonged operative and anesthesia time. Suture hole bleeding is common following using synthetic and biological grafts for vascular repair. Several topical hemostatic ans sealing agents have been developed to control suture line bleeding. This new vascular sealant possess high bonding properties, minimal tissue reaction, is biodegradable and absorbed by the body quickly. The primary focus of this study is to compare the safety and effectiveness of the vascular sealant with standard of care methods used today, specifically gelfoam/thrombin and sponge like material.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject was > 18 years of age. Scheduled for elective vascular surgery that entails placement of a PTFE vascular graft including extra-anatomic, infrainguinal bypass, and primary and secondary arteriovenous access procedures. Subject was willing and able to comply with all aspects of the treatment and evaluation schedule. Informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site
Exclusion Criteria:
Subject had a known local or systemic infection. Subjects with known coagulopathies including hemophilia, factor deficiencies, platelet count < 80,000 u/mL, heparin induced thrombocytopenia or uncorrected INR > 1.5. Subject was participating in a clinical trial that requires treatment with another investigational device or drug. Subject was lactating or pregnant, or does not agree to use contraception for the duration of the study. Subject had a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin. The investigator determined that the subject should not be included in the study for reason(s) not already specified
Contacts and Locations More Information
No publications provided
| Responsible Party: | Vladimir Scerbin - Sr.Director Clinical Affairs, Confluent Surgical |
| ClinicalTrials.gov Identifier: | NCT00439309 History of Changes |
| Other Study ID Numbers: | VAS-06-001 |
| Study First Received: | February 21, 2007 |
| Last Updated: | February 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
Thrombin Gelatin Sponge, Absorbable Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013