Peripheral Vascular DiseaseNCT01158261
The Evicel Post-Authorization Surveillance Study
An observational study of Peripheral Vascular Disease and Hemorrhage, run by Ethicon, Inc. at 2 sites in United States.
Trial summary
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease, Hemorrhage
- What is being tested?
- EVICEL ™ Fibrin Sealant (Human)
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to May 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects requiring elective vascular procedures
Who may be able to join
- Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery
- EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es
- Subjects must be willing to and capable of participating in the study, and provide written informed consent
Who cannot join
- Subjects with known intolerance to blood products
- Subjects unwilling to receive blood products
- Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding
- Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baptist Health Medical Center
Jacksonville, Florida, 32207
Memorial Hospital
Jacksonville, Florida, 32216
About this study
Official title: A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.
- Conditions
- Peripheral Vascular Disease, Hemorrhage
- Being tested
- EVICEL ™ Fibrin Sealant (Human)
- Keywords
- hemostasis
- Medical subject headings
- Peripheral Vascular Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVICEL ™ Fibrin Sealant (Human)Biological
Also called Fibrin Sealant (Human)
Commercial Evicel
| Study group | Role | What they receive |
|---|---|---|
| Vascular Surgery Subjects Treated with EVICEL | Not described Receives: Biological: EVICEL ™ Fibrin Sealant (Human) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Safety Parameters
- Incidence of graft occlusion
- Incidence of adverse events potentially related to non-graft thrombotic events
- Incidence of bleeding events
Measured: Up to 4-weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Vascular DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Richard Kocharian, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158261
- Sponsor's protocol ID
- 400-08-004
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2010
- Last updated
- 19 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery
- ClinicalTrials.gov ID
- NCT01158261
- Acronym / sponsor ID
- 400-08-004
- Conditions
- Peripheral Vascular Disease, Hemorrhage
- Keywords
- hemostasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Study start
- Jun 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Posted 19 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular Surgery Subjects Treated with EVICEL | – | Biological: EVICEL ™ Fibrin Sealant (Human) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects requiring elective vascular procedures
Key inclusion criteria (3 listed)
- Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery
- EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es
- Subjects must be willing to and capable of participating in the study, and provide written informed consent
Key exclusion criteria (4 listed)
- Subjects with known intolerance to blood products
- Subjects unwilling to receive blood products
- Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding
- Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery
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 |
|---|---|---|
| EVICEL ™ Fibrin Sealant (Human)Also: Fibrin Sealant (Human)Commercial Evicel | Biological | Vascular Surgery Subjects Treated with EVICEL |
Primary outcome
Specific Safety Parameters
Time frame: Up to 4-weeks post-operatively
* Incidence of graft occlusion * Incidence of adverse events potentially related to non-graft thrombotic events * Incidence of bleeding events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Kocharian, MD study director
Ethicon, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Disease and Hemorrhage, run by Ethicon, Inc. at 2 sites 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?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Specific Safety Parameters (time frame: Up to 4-weeks post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2015.