Prosthetic Vascular Graft InfectionVASGRANCT01821664
Vascular Graft Infections
An observational study of Prosthetic Vascular Graft Infection, run by University of Zurich at 1 site in Switzerland.
Trial summary
Background: Vascular grafts are increasingly implanted due to an increasing prevalence of atherosclerosis and diabetes, and about 1-6% of vascular procedures are complicated by infection. Mortality attributable to prosthetic vascular graft infections (PVGI) is high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Vascular Graft Infection
- What is being tested?
- Prosthetic vascular graft
- Type of treatment
- Medical device
- How many people
- 1,800 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Mar 2023
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a vascular surgery at the University hospital will be included in the study.
Who may be able to join
- Control patients:
- Vascular graft surgery (peripheral, aortic, vein)
- Case patients:
- Patients with previous primary implantation of an aortic or peripheral vascular implant and suspicion of PVGI
- Age >18 years
- Written informed consent
Who cannot join
- Drug or alcohol abuse
- Involvement in a conflicting clinical trial (investigational drug)
- Inability to follow the procedures of the cohort, e.g. due to language problems, psychological disorders or dementia of the subject
- Known or suspected non-compliance
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology
Zurich, Canton of Zurich, 8091
About this study
Official title: Vascular Graft Infections - Epidemiology, Best Treatment Options, Imaging Modalities and Impact of Negative Pressure Wound Therapy
Background: Vascular grafts are increasingly implanted due to an increasing prevalence of atherosclerosis and diabetes, and about 1-6% of vascular procedures are complicated by infection. Mortality attributable to prosthetic vascular graft infections (PVGI) is high. However, there are almost no data regarding best treatment options of such complicated infections. Most recommendations are based on expert opinion and not on clinical trials or cohort observational data analyses. Evaluating infectious and other complications after vascular surgery procedures are important, and additionally, such studies may offer insights for quality improvement and improved patient outcomes. With the first aim investigators will establish an infrastructure for studying PVGI in Zurich. Investigators will take advantage of the Swissvasc registry, a central registry which collects preoperative, operative and discharge data regarding the index vascular surgical interventions. They will create a prospective observational cohort database of all patients who receive a vascular graft (peripheral, aortic, vein) at the University hospital of Zurich (VASGRA Cohort A). Patients with a PVGI will be included in VASGRA Cohort B and followed up using a flow chart with a focus on the course of this infectious complication. Additionally, investigators will establish a biobank with the collection of tissue- and blood samples of patients with PVGI. With the second aim researchers will investigate different diagnostic, clinical and therapeutic research questions nested in the VASGRA Cohort. Firstly, they will address epidemiological questions, such as: determine the incidence and outcome of complications after vascular graft placement; determine risk factors, best treatment strategies and outcome of PVGI, and determine the influence of different antibiotic regimens on the outcome of PVGI due to different bacterial pathogens. Secondly, investigators will determine the accuracy of different imaging techniques (PET/CT and MRI) for the diagnosis of PVGI, and their individual role for the assessment of treatment response. Thirdly, investigators will evaluate the bacterial diversity of vascular wound infections using 16s r-Ribonucleic acid (RNA)amplification, and investigators will explore whether this bacterial diversity does predict disease progression. Here, investigators will also study the impact of negative pressure wound therapy (NPWT) on bacterial diversity in the treatment course of PVGI. Fourthly, investigators will look for cut-off levels of relevant blood leucocytes count, C-reactive protein and procalcitonin raising suspicion of a PVGI. Lastly, investigators will look at histopathological features of excised vascular grafts. Expected value of the project: Results from the proposed study are an important contribution to the field, based on the large sample size, longitudinal design and by unifying clinical and epidemiological science. The very well characterized patient groups and the close connection between vascular surgeons, infectious disease specialists, specialists in nuclear medicine and microbiologist will help to investigate PVGI in depths. Investigators hope to be able to develop guidelines regarding best diagnostic modalities and treatment options in case of vascular graft infections. In the future we plan to examine bacteria retrieved from the PVGI in the laboratory in detail. The recovered bacteria will be examined for antimicrobial susceptibility and their capability to form biofilms. Furthermore investigators will examine how bacterial recovery form explanted grafts could be optimized.
- Conditions
- Prosthetic Vascular Graft Infection
- Being tested
- Prosthetic vascular graft
- Keywords
- Prosthetic vascular graft infection, negative pressure wound therapy, microbiology, antimicrobial therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic vascular graftDevice
Also called Valsalva Graft, Gelwave TM, Subclavia Graft, Gelwave TM, Longer Ante-Flo Offset branch, Gelwave TM, Lupiae Branched Graft, Gelwave TM
Implantation of a prosthetic vascular graft
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic vascular graft implantation, follow up | Not described Receives: Device: Prosthetic vascular graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular graft infection
Persons are followed up after vascular graft surgery.
Measured: within 10 years
Secondary outcomes (3)
Bleeding
Measured: 10 years
Foreign body reaction
Measured: 10 years
All cause- mortality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prosthetic Vascular Graft InfectionStudies 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
- 1,800 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Schweizerischer Nationalfonds
- Responsible party
- Sponsor
- Investigators
- Barbara Hasse, MD, Principal investigator, University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821664
- Sponsor's protocol ID
- KEK-ZH-Nr. 2012-0583
- Acronym
- VASGRA
- Status last verified
- May 2015
- First submitted
- 7 Mar 2013
- Last updated
- 6 May 2015
- Results posted
- No
Publications
Husmann L, Huellner MW, Ledergerber B, Anagnostopoulos A, Stolzmann P, Sah BR, Burger IA, Rancic Z, Hasse B; and the Vasgra Cohort. Comparing diagnostic accuracy of 18F-FDG-PET/CT, contrast enhanced CT and combined imaging in patients with suspected vascular graft infections. Eur J Nucl Med Mol Imaging. 2019 Jun;46(6):1359-1368. doi: 10.1007/s00259-018-4205-y. Epub 2018 Nov 13.
PubMed 30426151Anagnostopoulos A, Ledergerber B, Kuster SP, Scherrer AU, Naf B, Greiner MA, Rancic Z, Kobe A, Bettex D, Hasse B; VASGRA Cohort Study. Inadequate Perioperative Prophylaxis and Postsurgical Complications After Graft Implantation Are Important Risk Factors for Subsequent Vascular Graft Infections: Prospective Results From the Vascular Graft Infection Cohort Study. Clin Infect Dis. 2019 Aug 1;69(4):621-630. doi: 10.1093/cid/ciy956.
PubMed 30395220Husmann L, Ledergerber B, Anagnostopoulos A, Stolzmann P, Sah BR, Burger IA, Pop R, Weber A, Mayer D, Rancic Z, Hasse B; VASGRA Cohort Study. The role of FDG PET/CT in therapy control of aortic graft infection. Eur J Nucl Med Mol Imaging. 2018 Oct;45(11):1987-1997. doi: 10.1007/s00259-018-4069-1. Epub 2018 Jun 11.
PubMed 29948106Ajdler-Schaeffler E, Scherrer AU, Keller PM, Anagnostopoulos A, Hofmann M, Rancic Z, Zinkernagel AS, Bloemberg GV, Hasse BK; and the VASGRA Cohort. Increased Pathogen Identification in Vascular Graft Infections by the Combined Use of Tissue Cultures and 16S rRNA Gene Polymerase Chain Reaction. Front Med (Lausanne). 2018 Jun 4;5:169. doi: 10.3389/fmed.2018.00169. eCollection 2018.
PubMed 29915786Husmann L, Sah BR, Scherrer A, Burger IA, Stolzmann P, Weber R, Rancic Z, Mayer D, Hasse B; VASGRA Cohort. (1)(8)F-FDG PET/CT for Therapy Control in Vascular Graft Infections: A First Feasibility Study. J Nucl Med. 2015 Jul;56(7):1024-9. doi: 10.2967/jnumed.115.156265. Epub 2015 May 14.
PubMed 25977463
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Graft Infections - Epidemiology, Best Treatment Options, Imaging Modalities and Impact of Negative Pressure Wound Therapy
- ClinicalTrials.gov ID
- NCT01821664
- Acronym / sponsor ID
- VASGRA / KEK-ZH-Nr. 2012-0583
- Conditions
- Prosthetic Vascular Graft Infection
- Keywords
- Prosthetic vascular graft infection, negative pressure wound therapy, microbiology, antimicrobial therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Schweizerischer Nationalfonds
- Study start
- May 2013
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 1 Apr 2013 (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.
Background: Vascular grafts are increasingly implanted due to an increasing prevalence of atherosclerosis and diabetes, and about 1-6% of vascular procedures are complicated by infection. Mortality attributable to prosthetic vascular graft infections (PVGI) is high. However, there are almost no data regarding best treatment options of such complicated infections. Most recommendations are based on expert opinion and not on clinical trials or cohort observational data analyses. Evaluating infectious and other complications after vascular surgery procedures are important, and additionally, such studies may offer insights for quality improvement and improved patient outcomes. With the first aim investigators will establish an infrastructure for studying PVGI in Zurich. Investigators will take advantage of the Swissvasc registry, a central registry which collects preoperative, operative and discharge data regarding the index vascular surgical interventions. They will create a prospective observational cohort database of all patients who receive a vascular graft (peripheral, aortic, vein) at the University hospital of Zurich (VASGRA Cohort A). Patients with a PVGI will be included in VASGRA Cohort B and followed up using a flow chart with a focus on the course of this infectious complication. Additionally, investigators will establish a biobank with the collection of tissue- and blood samples of patients with PVGI. With the second aim researchers will investigate different diagnostic, clinical and therapeutic research questions nested in the VASGRA Cohort. Firstly, they will address epidemiological questions, such as: determine the incidence and outcome of complications after vascular graft placement; determine risk factors, best treatment strategies and outcome of PVGI, and determine the influence of different antibiotic regimens on the outcome of PVGI due to different bacterial pathogens. Secondly, investigators will determine the accuracy of different imaging techniques (PET/CT and MRI) for the diagnosis of PVGI, and their individual role for the assessment of treatment response. Thirdly, investigators will evaluate the bacterial diversity of vascular wound infections using 16s r-Ribonucleic acid (RNA)amplification, and investigators will explore whether this bacterial diversity does predict disease progression. Here, investigators will also study the impact of negative pressure wound therapy (NPWT) on bacterial diversity in the treatment course of PVGI. Fourthly, investigators will look for cut-off levels of relevant blood leucocytes count, C-reactive protein and procalcitonin raising suspicion of a PVGI. Lastly, investigators will look at histopathological features of excised vascular grafts. Expected value of the project: Results from the proposed study are an important contribution to the field, based on the large sample size, longitudinal design and by unifying clinical and epidemiological science. The very well characterized patient groups and the close connection between vascular surgeons, infectious disease specialists, specialists in nuclear medicine and microbiologist will help to investigate PVGI in depths. Investigators hope to be able to develop guidelines regarding best diagnostic modalities and treatment options in case of vascular graft infections. In the future we plan to examine bacteria retrieved from the PVGI in the laboratory in detail. The recovered bacteria will be examined for antimicrobial susceptibility and their capability to form biofilms. Furthermore investigators will examine how bacterial recovery form explanted grafts could be optimized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthetic vascular graft implantation, follow up | – | Device: Prosthetic vascular graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a vascular surgery at the University hospital will be included in the study.
Key inclusion criteria (6 listed)
- Vascular graft surgery (peripheral, aortic, vein)
- Patients with previous primary implantation of an aortic or peripheral vascular implant and suspicion of PVGI
- Age >18 years
- Written informed consent
Key exclusion criteria (4 listed)
- Drug or alcohol abuse
- Involvement in a conflicting clinical trial (investigational drug)
- Inability to follow the procedures of the cohort, e.g. due to language problems, psychological disorders or dementia of the subject
- Known or suspected non-compliance
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 |
|---|---|---|
| Prosthetic vascular graftAlso: Valsalva Graft, Gelwave TM, Subclavia Graft, Gelwave TM, Longer Ante-Flo Offset branch, Gelwave TM, Lupiae Branched Graft, Gelwave TMImplantation of a prosthetic vascular graft | Device | Prosthetic vascular graft implantation, follow up |
Primary outcome
Vascular graft infection
Time frame: within 10 years
Persons are followed up after vascular graft surgery.
3 secondary outcomes
Bleeding
Time frame: 10 years
Foreign body reaction
Time frame: 10 years
All cause- mortality
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Derived from this study: PubMed 30426151Husmann L, Huellner MW, Ledergerber B, Anagnostopoulos A, Stolzmann P, Sah BR, Burger IA, Rancic Z, Hasse B; and the Vasgra Cohort. Comparing diagnostic accuracy of 18F-FDG-PET/CT, contrast enhanced CT and combined imaging in patients with suspected vascular graft infections. Eur J Nucl Med Mol Imaging. 2019 Jun;46(6):1359-1368. doi: 10.1007/s00259-018-4205-y. Epub 2018 Nov 13.
- Derived from this study: PubMed 30395220Anagnostopoulos A, Ledergerber B, Kuster SP, Scherrer AU, Naf B, Greiner MA, Rancic Z, Kobe A, Bettex D, Hasse B; VASGRA Cohort Study. Inadequate Perioperative Prophylaxis and Postsurgical Complications After Graft Implantation Are Important Risk Factors for Subsequent Vascular Graft Infections: Prospective Results From the Vascular Graft Infection Cohort Study. Clin Infect Dis. 2019 Aug 1;69(4):621-630. doi: 10.1093/cid/ciy956.
- Derived from this study: PubMed 29948106Husmann L, Ledergerber B, Anagnostopoulos A, Stolzmann P, Sah BR, Burger IA, Pop R, Weber A, Mayer D, Rancic Z, Hasse B; VASGRA Cohort Study. The role of FDG PET/CT in therapy control of aortic graft infection. Eur J Nucl Med Mol Imaging. 2018 Oct;45(11):1987-1997. doi: 10.1007/s00259-018-4069-1. Epub 2018 Jun 11.
- Derived from this study: PubMed 29915786Ajdler-Schaeffler E, Scherrer AU, Keller PM, Anagnostopoulos A, Hofmann M, Rancic Z, Zinkernagel AS, Bloemberg GV, Hasse BK; and the VASGRA Cohort. Increased Pathogen Identification in Vascular Graft Infections by the Combined Use of Tissue Cultures and 16S rRNA Gene Polymerase Chain Reaction. Front Med (Lausanne). 2018 Jun 4;5:169. doi: 10.3389/fmed.2018.00169. eCollection 2018.
- Derived from this study: PubMed 25977463Husmann L, Sah BR, Scherrer A, Burger IA, Stolzmann P, Weber R, Rancic Z, Mayer D, Hasse B; VASGRA Cohort. (1)(8)F-FDG PET/CT for Therapy Control in Vascular Graft Infections: A First Feasibility Study. J Nucl Med. 2015 Jul;56(7):1024-9. doi: 10.2967/jnumed.115.156265. Epub 2015 May 14.
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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.
Barbara Hasse, MD principal investigator
University Hospital Zurich, Div of Infectious Diseases and Hospital Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic Vascular Graft Infection, run by University of Zurich at 1 site in Switzerland.
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 6 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: status not confirmed, as of the sponsor's last update on 6 May 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Hasse, MD (+41 (0)44 255 11 11, barbara.hasse@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular graft infection (time frame: within 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01821664, which also lists 5 linked publications.
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 6 May 2015; AzTrials last refreshed its copy on 27 Oct 2026.