Arteriovenous Access Grafts or Extra-anatomic and Infra-inguinal GraftsPhase 1VSSNCT00618358
Vascular Sealant Study
A Phase 1 study testing Vascular Sealant System and Gelfoam/Thrombin in people with Arteriovenous Access Grafts or Extra-anatomic and Infra-inguinal Grafts, run by Georgetown University at 1 site in United States.
Trial summary
Study Objective:To evaluate the safety and effectiveness of the Vascular Sealant compared with Gelfoam/Thrombin when used to seal bleeding anastomotic suture lines in patients undergoing vascular reconstructive surgery requiring placement of a PTFE graft (including extra-anatomic, infrainguinal bypass and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Access Grafts or Extra-anatomic and Infra-inguinal Grafts
- What is being tested?
- Vascular Sealant System and Gelfoam/Thrombin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Preoperative Inclusion Criteria:
Subjects must meet all of the following criteria to be eligible for participation in the study:
- > 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 is 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
Preoperative Exclusion Criteria: Subjects who meet any of the following criteria are not eligible for participation in the study:
- Subject has a known local or systemic infection
- Subjects with known coagulapathies including hemophilia, factor deficiencies, platelet count < 80,000 u/mL, heparin induced thrombocytopenia or uncorrected INR > 1.5
- Subject is participating in a clinical trial that requires treatment with another investigational device or drug
- Subject is lactating or pregnant, or does not agree to use contraception for the duration of the study
- Subject has a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin
- The investigator determines that the subject should not be included in the study for reason(s) not already specified
Intraoperative Inclusion Criteria: Subjects must meet the following intraoperative inclusion criteria to be eligible for randomization:
- Suture line leaks (bleeding) confirmed prior to randomization.
Intraoperative Exclusion Criteria: Subjects who meet any of the following intraoperative exclusion criteria are considered screening failures and are not eligible to be randomized:
- Incidental finding of any of the preoperative exclusion criteria
- Subject has obvious contamination or a concurrent systemic infection
- Investigator determines that participation in the study may jeopardize the safety or welfare of the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: A Prospective, Randomized, Multi-Center, Two Arm Study to Evaluate the Safety and Effectiveness of the Vascular Sealant System Compared With Gelfoam/Thrombin for Control of Anastomosis Suture Line Bleeding in Patients Undergoing Vascular Reconstructive Surgery With PTFE Grafts
Study Objective:To evaluate the safety and effectiveness of the Vascular Sealant compared with Gelfoam/Thrombin when used to seal bleeding anastomotic suture lines in patients undergoing vascular reconstructive surgery requiring placement of a PTFE graft (including extra-anatomic, infrainguinal bypass and arteriovenous (AV) access procedures).
Study Design: The study is a multi-center, prospective, randomized controlled clinical trial that will compare two methods for treating anastomotic leakage (bleeding). All subjects (n =151) will be randomized at a 3:1 ratio to receive either the investigational treatment (Vascular Sealant) or the control treatment (Gelfoam/Thrombin). Up to two (2) treatment sites may be evaluated for each subject. Subjects will be stratified by type of graft procedure: AV access graft or extra-anatomic and infra-inguinal graft. A minimum of 60 patients, and a maximum of 91 patients, will be enrolled in each stratum. Treatment randomization will be blocked by center and type of graft procedure (e.g., bypass or AV grafts). All subjects will undergo preoperative screening to determine eligibility and will be evaluated intraoperatively, at discharge or within 7 days of surgery, and 30 days post-procedure to monitor for hematologic disturbances, hemorrhagic events, wound complications and other potential acute post-operative adverse events.
Read more
Up to ten (10) investigational sites will participate in the study. Enrollment is expected to take approximately 8 months for an anticipated duration of the clinical investigation of approximately 9 to 10 months.
The primary objective of this trial is to demonstrate non-inferiority of the Vascular Sealant to Gelfoam/Thrombin when used to seal anastomotic suture lines in patients undergoing placement of PTFE vascular grafts (including extra-anatomic, infrainguinal bypass and arteriovenous access procedures).
- Being tested
- Vascular Sealant System, Gelfoam/Thrombin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Sealant SystemDevice
The Vascular Sealant System is intended for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Gelfoam/ThrombinOther
| Study group | Role | What they receive |
|---|---|---|
| Vascular Sealant) | Experimental | Not described Receives: Device: Vascular Sealant System |
| Gelfoam/Thrombin | Active comparator | Not described Receives: Other: Gelfoam/Thrombin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startMar 2007
Why it stopped: Sponsor - Confluent Surgical terminated study re: surgical techniques Letter dated 4/31/2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous Access Grafts or Extra-anatomic and Infra-inguinal GraftsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Investigators
- David Deaton, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618358
- Sponsor's protocol ID
- 2007-072
- Acronym
- VSS
- Status last verified
- Jan 2010
- First submitted
- 8 Feb 2008
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
PubMed 38695613
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center, Two Arm Study to Evaluate the Safety and Effectiveness of the Vascular Sealant System Compared With Gelfoam/Thrombin for Control of Anastomosis Suture Line Bleeding in Patients Undergoing Vascular Reconstructive Surgery With PTFE Grafts
- ClinicalTrials.gov ID
- NCT00618358
- Acronym / sponsor ID
- VSS / 2007-072
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor - Confluent Surgical terminated study re: surgical techniques Letter dated 4/31/2008
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Mar 2007
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Objective:To evaluate the safety and effectiveness of the Vascular Sealant compared with Gelfoam/Thrombin when used to seal bleeding anastomotic suture lines in patients undergoing vascular reconstructive surgery requiring placement of a PTFE graft (including extra-anatomic, infrainguinal bypass and arteriovenous (AV) access procedures).
Study Design: The study is a multi-center, prospective, randomized controlled clinical trial that will compare two methods for treating anastomotic leakage (bleeding). All subjects (n =151) will be randomized at a 3:1 ratio to receive either the investigational treatment (Vascular Sealant) or the control treatment (Gelfoam/Thrombin). Up to two (2) treatment sites may be evaluated for each subject. Subjects will be stratified by type of graft procedure: AV access graft or extra-anatomic and infra-inguinal graft. A minimum of 60 patients, and a maximum of 91 patients, will be enrolled in each stratum. Treatment randomization will be blocked by center and type of graft procedure (e.g., bypass or AV grafts). All subjects will undergo preoperative screening to determine eligibility and will be evaluated intraoperatively, at discharge or within 7 days of surgery, and 30 days post-procedure to monitor for hematologic disturbances, hemorrhagic events, wound complications and other potential acute post-operative adverse events.
Up to ten (10) investigational sites will participate in the study. Enrollment is expected to take approximately 8 months for an anticipated duration of the clinical investigation of approximately 9 to 10 months.
The primary objective of this trial is to demonstrate non-inferiority of the Vascular Sealant to Gelfoam/Thrombin when used to seal anastomotic suture lines in patients undergoing placement of PTFE vascular grafts (including extra-anatomic, infrainguinal bypass and arteriovenous access procedures).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascular Sealant) | Experimental | Device: Vascular Sealant System |
| Gelfoam/Thrombin | Active comparator | Other: Gelfoam/Thrombin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular Sealant SystemThe Vascular Sealant System is intended for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. | Device | Vascular Sealant) |
| Gelfoam/Thrombin | Other | Gelfoam/Thrombin |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Sponsor - Confluent Surgical terminated study re: surgical techniques Letter dated 4/31/2008). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Derived from this study: PubMed 38695613Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Deaton, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vascular Sealant System and Gelfoam/Thrombin in people with Arteriovenous Access Grafts or Extra-anatomic and Infra-inguinal Grafts, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor - Confluent Surgical terminated study re: surgical techniques Letter dated 4/31/2008). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00618358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.