Vascular Graft InfectionCAIGISNCT07847346
China Aortic Infection and Graft Infection Study: An Ambispective Cohort
An observational study of Vascular Graft Infection and Infectious Aortitis, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Vascular infections are uncommon but severe infections involving the arterial wall, vascular grafts, or endografts, and their diagnosis and management remain challenging. The CAIGIS Cohort is an ambispective observational cohort established at Zhongshan Hospital, Fudan University, to create an integrated clinical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Graft Infection, Infectious Aortitis, Aortoenteric Fistula
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 1 Nov 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of consecutive adult patients evaluated or treated at Zhongshan Hospital, Fudan University, for suspected or confirmed vascular infections involving the native arterial wall, vascular grafts, or endografts. The cohort includes infectious aortitis, infected arterial aneurysms, vascular graft or endograft infections, and fistula-associated vascular infections. The ambispective design includes retrospectively identified patients with adequate clinical records and prospectively enrolled patients undergoing longitudinal follow-up. Clinical, microbiological, imaging, treatment, and outcome data will be collected, and biospecimens will be retained when available. Final diagnostic classification will be determined by multidisciplinary adjudication integrating clinical presentation, microbiological and molecular findings, imaging, pathology, operative findings, and longitudinal clinical course.
Who may be able to join
- Adults aged 18 years or older.
- Patients with suspected or confirmed vascular infection involving the native arterial wall, vascular graft, or endograft, including but not limited to infectious aortitis, infected arterial aneurysm, vascular graft or endograft infection, and fistula-associated vascular infection.
- Patients evaluated or treated at Zhongshan Hospital, Fudan University, with sufficient clinical information to allow diagnostic adjudication and outcome assessment.
- For the prospective cohort, willingness to participate and provide informed consent when required.
- For the retrospective cohort, availability of relevant clinical records meeting the requirements approved by the institutional ethics committee.
Who cannot join
- Isolated superficial surgical-site infection without evidence of involvement of the arterial wall, vascular graft, or endograft.
- Insufficient clinical data to permit diagnostic adjudication or longitudinal outcome assessment.
- Refusal to participate in the prospective component when informed consent is required.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jianing Yue, MD, PhD contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, 200032
QING MIAO, MD,PHD, +8613917763967, miao.qing@zs-hospital.sh.cn
About this study
Official title: Clinical Characteristics, Treatment Strategies, and Prognostic Factors of Infectious Arterial Diseases: A Single-Center, Real-World, Ambispective Observational Cohort Study
Vascular infections are uncommon but severe infections involving the arterial wall, vascular grafts, or endografts, and their diagnosis and management remain challenging. The CAIGIS Cohort is an ambispective observational cohort established at Zhongshan Hospital, Fudan University, to create an integrated clinical research platform and biobank for patients with suspected or confirmed vascular infections.
The primary research focus is the diagnosis and characterization of causative pathogens. Conventional microbiological methods and emerging molecular diagnostic technologies will be systematically evaluated, with particular emphasis on blood-based pathogen detection as a form of liquid biopsy and its diagnostic value compared with local tissue or operative specimens. Serial blood samples and tissue specimens, when available, will also be used to investigate biomarkers associated with treatment response and clinical outcomes.
Read more
Another major focus is the role of molecular imaging, particularly 18F-FDG PET/CT, in the diagnosis and longitudinal assessment of vascular infections. The study will evaluate its diagnostic performance, its added value in patients with inconclusive conventional imaging, and the potential significance of changes in metabolic activity during follow-up for assessing treatment response, residual infection, recurrence, and prognosis.
The cohort will further support nested translational studies addressing specific pathogen- and disease-related questions. These include longitudinal characterization of microbial communities in patients with vascular-enteric fistulas; evaluation of the clinical significance and invasive potential of Candida species; investigation of the clinical and biological characteristics of mycobacterial vascular infections; and exploration of pathogen-host interactions within infected vascular tissues.
By integrating longitudinal clinical data, microbiological results, molecular diagnostics, PET/CT findings, treatment information, outcomes, and biospecimens, the cohort aims to improve etiological diagnosis, disease stratification, treatment monitoring, prognostic assessment, and understanding of the pathogenesis of vascular infections.
Read the detailed description
Vascular infections encompass a heterogeneous group of severe infectious diseases involving the arterial wall, vascular grafts, or endografts, including infectious aortitis, infected arterial aneurysms, vascular graft and endograft infections, and fistula-associated vascular infections. These conditions are associated with substantial morbidity and mortality and remain challenging with respect to etiological diagnosis, assessment of disease activity, therapeutic decision-making, and prediction of recurrence and long-term outcomes.
The CAIGIS Cohort is an ambispective observational cohort established at Zhongshan Hospital, Fudan University. The study is designed as a longitudinal clinical research platform integrating standardized clinical data, microbiological investigations, molecular diagnostics, imaging, treatment information, outcome assessment, and longitudinal biospecimen collection. Patients with suspected or confirmed vascular infections will be included and followed longitudinally. In addition to characterization of the overall disease spectrum, the cohort will serve as a platform for multiple nested diagnostic, prognostic, microbiological, imaging, and translational studies.
Etiological diagnosis and evaluation of diagnostic technologies constitute a major focus of the cohort. Conventional microbiological methods, including blood culture, operative specimen culture, histopathology, and pathogen-specific serological testing, will be evaluated together with emerging molecular diagnostic technologies. Particular attention will be given to blood-based pathogen detection as a form of liquid biopsy, including metagenomic and targeted sequencing approaches where available. Diagnostic yield, incremental diagnostic value, time to etiological diagnosis, concordance between blood and local-site specimens, and the clinical impact of different diagnostic strategies will be investigated. Operative tissue and prosthetic material, when available, will provide an important reference for evaluating blood-based diagnostic approaches.
The cohort will also investigate dynamic biomarkers for disease activity and prognosis. Serial blood samples obtained during diagnosis, treatment, and follow-up may be used to characterize changes in pathogen-derived signals and host-response biomarkers. Their associations with microbiological clearance, treatment response, persistent infection, recurrence, reoperation, and mortality will be explored. The long-term objective is to develop integrated diagnostic and prognostic models combining clinical, microbiological, molecular, imaging, and host-response information.
A further research focus is the role of 18F-FDG PET/CT and other imaging modalities in both diagnosis and longitudinal monitoring. The diagnostic performance and incremental value of PET/CT, particularly in patients with inconclusive conventional imaging, will be evaluated. Where serial PET/CT examinations are clinically available, changes in metabolic activity and imaging patterns will be studied in relation to treatment response, residual infection, recurrence, and prognosis. Quantitative and semi-quantitative imaging parameters may be integrated with microbiological and biomarker data to investigate whether multimodal assessment can improve disease classification and therapeutic monitoring.
Fistula-associated vascular infection, particularly vascular-enteric fistula-associated infection, represents another key area of investigation. These patients often demonstrate complex polymicrobial patterns and may undergo substantial changes in microbial composition during antimicrobial treatment, surgery, and postoperative recovery. Serial blood, operative tissue, fistula-adjacent specimens, and other clinically obtained samples may therefore be used to characterize the longitudinal dynamics of microbial communities, distinguish vascular pathogens from enteric-source organisms, and explore the relationship between microbial composition, fistula status, treatment strategy, and clinical outcome.
The cohort will also support pathogen-specific translational studies. For Candida species, research will focus on distinguishing colonization or contamination from clinically significant invasive vascular infection and identifying microbiological, imaging, host, and clinical features associated with invasive disease and adverse outcomes. For mycobacterial vascular infections, including infections caused by Mycobacterium tuberculosis and nontuberculous mycobacteria, studies will investigate clinical characteristics, diagnostic features, microbial determinants, host susceptibility, and potential mechanisms underlying vascular tropism and persistent infection.
In patients undergoing surgery, infected vascular tissues and prosthetic materials may additionally be used to investigate in situ pathogen-host interactions. These studies may examine the spatial distribution of pathogens within infected tissue, local inflammatory and immune responses, tissue injury, and the relationship between microbial localization and pathological phenotype. Depending on specimen availability and individual nested study protocols, approaches may include microbiological, histopathological, molecular, genomic, transcriptomic, and spatial analyses.
Through the integration of clinical phenotyping, longitudinal biospecimen collection, pathogen-oriented diagnostics, liquid biopsy, molecular imaging, prognostic biomarkers, and translational investigation, the CAIGIS Cohort aims to establish a comprehensive research infrastructure for vascular infections. The overarching goal is to improve etiological diagnosis, disease stratification, treatment monitoring, prognostic assessment, and mechanistic understanding of these complex infections.
- Keywords
- Vascular graft and endograft infection, Infectious aneurysm, Aortoenteric fistula, Metagenomic next-generation sequencing, Liquid biopsy, 18F-FDG PET/CT, Mycobacterium, Pathogen-host interaction, Microbiome
- Medical subject headings
- Mycobacterium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Vascular Infections | Patients with suspected or confirmed vascular infections, including infectious aortitis, infected arterial aneurysms, vascular graft or endograft infections, and fistula-associated vascular infections. Clinical, microbiological, molecular diagnostic, imaging, treatment, outcome, and biospecimen data will be collected longitudinally to support diagnostic, prognostic, and translational studies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Cure Rate One Year After Discontinuation of Antimicrobial Therapy
Proportion of participants who remain alive and free from persistent or recurrent vascular infection for 1 year after discontinuation of antimicrobial therapy, without reinitiation of antimicrobial treatment for the index vascular infection or unplanned infection-related surgical or endovascular intervention.
Measured: 1 year after discontinuation of antimicrobial therapy
Five-Year All-Cause Mortality
Proportion of participants who die from any cause within 5 years after the index diagnosis of vascular infection.
Measured: 5 years after the index diagnosis
Secondary outcomes (2)
Proportion of Patients Requiring Lifelong Suppressive Antimicrobial Therapy
Proportion of participants requiring indefinite or lifelong suppressive antimicrobial therapy because complete eradication of vascular infection is not considered achievable. The proportion will be assessed separately among patients managed conservatively and those undergoing surgical or endovascular treatment.
Measured: Up to 2 years after diagnosis
Five-Year Infection-Related Mortality
Percentage of participants who die from causes directly or indirectly attributable to the index vascular infection within 5 years after the index diagnosis. Infection-related death will be determined by multidisciplinary clinical adjudication based on the clinical course, microbiological findings, imaging, operative findings, and documented cause of death.
Measured: Up to 5 years after the index diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2036 (estimated)
- Study completion1 Nov 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vascular Graft InfectionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Miao, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847346
- Sponsor's protocol ID
- CAIGIS-202611
- Acronym
- CAIGIS
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in peer-reviewed publications may be shared upon reasonable request. Data sharing will be subject to approval by the study investigators and relevant institutional or ethics committees, and will comply with applicable privacy, data protection, and regulatory requirements. Data containing potentially identifiable, genomic, or other sensitive information may be subject to additional restrictions.
Publications
Linder KA, Miceli MH. Impact of Metagenomic Next-Generation Sequencing of Plasma Cell-free DNA Testing in the Management of Patients With Suspected Infectious Diseases. Open Forum Infect Dis. 2023 Jul 24;10(8):ofad385. doi: 10.1093/ofid/ofad385. eCollection 2023 Aug.
PubMed 37601730Lauri C, Signore A, Glaudemans AWJM, Treglia G, Gheysens O, Slart RHJA, Iezzi R, Prakken NHJ, Debus ES, Honig S, Lejay A, Chakfe N. Evidence-based guideline of the European Association of Nuclear Medicine (EANM) on imaging infection in vascular grafts. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3430-3451. doi: 10.1007/s00259-022-05769-x. Epub 2022 Apr 4.
PubMed 35376992Husmann 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 25977463Ajdler-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 29915786Anagnostopoulos A, Mayer F, Ledergerber B, Bergada-Pijuan J, Husmann L, Mestres CA, Rancic Z, Hasse B; VASGRA Cohort Study. Editor's Choice - Validation of the Management of Aortic Graft Infection Collaboration (MAGIC) Criteria for the Diagnosis of Vascular Graft/Endograft Infection: Results from the Prospective Vascular Graft Cohort Study. Eur J Vasc Endovasc Surg. 2021 Aug;62(2):251-257. doi: 10.1016/j.ejvs.2021.05.010. Epub 2021 Jun 14.
PubMed 34140225Lyons OT, Baguneid M, Barwick TD, Bell RE, Foster N, Homer-Vanniasinkam S, Hopkins S, Hussain A, Katsanos K, Modarai B, Sandoe JA, Thomas S, Price NM. Diagnosis of Aortic Graft Infection: A Case Definition by the Management of Aortic Graft Infection Collaboration (MAGIC). Eur J Vasc Endovasc Surg. 2016 Dec;52(6):758-763. doi: 10.1016/j.ejvs.2016.09.007. Epub 2016 Oct 19.
PubMed 27771318Sorelius K, Verhoek R, Berard X, Lyons OTA, Puges M, Wyss TR; International Expert Panel on Vascular Graft and Endograft Infections; European Society for Vascular Surgery Clinical Practice Guidelines on the Management of Vascular Graft and Endograft Infections Writing Committee. Vascular Graft and Endograft Infections: A Delphi Consensus Document on Terminology, Definitions, Treatment, Outcomes, Follow Up, and Reporting Standards. Eur J Vasc Endovasc Surg. 2026 Mar;71(3):497-507. doi: 10.1016/j.ejvs.2025.07.044. Epub 2025 Jul 29.
PubMed 40744353Lejay A, Saleem BR, Barwick TD, Beck AW, Berard X, Eilenberg W, Gavali H, Hasse B, Heinola I, Lyons OT, Perini P, Puges M, Price NM, Sorelius K, Wouthuyzen-Bakker M, Wyss TR, Boyle J, Dias NV, van Herzeele I, Lepidi S, Mees BME, Resch T, Ribeiro TF, Trimarchi S, Wanhainen A, Chakfe N, Hernandez-Meneses M, Kahlberg A, Khashram M, Szeberin Z, Zeebregts C. Editor's Choice - European Society for Vascular Surgery (ESVS) 2026 Clinical Practice Guidelines on the Management of Vascular Graft and Endograft Infections. Eur J Vasc Endovasc Surg. 2026 Aug;72(2):227-293. doi: 10.1016/j.ejvs.2026.05.035. Epub 2026 Jul 14.
PubMed 42448560
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics, Treatment Strategies, and Prognostic Factors of Infectious Arterial Diseases: A Single-Center, Real-World, Ambispective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07847346
- Acronym / sponsor ID
- CAIGIS / CAIGIS-202611
- Keywords
- Vascular graft and endograft infection, Infectious aneurysm, Aortoenteric fistula, Metagenomic next-generation sequencing, Liquid biopsy, 18F-FDG PET/CT, Mycobacterium, Pathogen-host interaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2036 (estimated)
- Study completion
- 1 Nov 2041 (estimated)
- First posted
- 29 Sep 2026 (actual)
- 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.
Vascular infections are uncommon but severe infections involving the arterial wall, vascular grafts, or endografts, and their diagnosis and management remain challenging. The CAIGIS Cohort is an ambispective observational cohort established at Zhongshan Hospital, Fudan University, to create an integrated clinical research platform and biobank for patients with suspected or confirmed vascular infections.
The primary research focus is the diagnosis and characterization of causative pathogens. Conventional microbiological methods and emerging molecular diagnostic technologies will be systematically evaluated, with particular emphasis on blood-based pathogen detection as a form of liquid biopsy and its diagnostic value compared with local tissue or operative specimens. Serial blood samples and tissue specimens, when available, will also be used to investigate biomarkers associated with treatment response and clinical outcomes.
Another major focus is the role of molecular imaging, particularly 18F-FDG PET/CT, in the diagnosis and longitudinal assessment of vascular infections. The study will evaluate its diagnostic performance, its added value in patients with inconclusive conventional imaging, and the potential significance of changes in metabolic activity during follow-up for assessing treatment response, residual infection, recurrence, and prognosis.
The cohort will further support nested translational studies addressing specific pathogen- and disease-related questions. These include longitudinal characterization of microbial communities in patients with vascular-enteric fistulas; evaluation of the clinical significance and invasive potential of Candida species; investigation of the clinical and biological characteristics of mycobacterial vascular infections; and exploration of pathogen-host interactions within infected vascular tissues.
By integrating longitudinal clinical data, microbiological results, molecular diagnostics, PET/CT findings, treatment information, outcomes, and biospecimens, the cohort aims to improve etiological diagnosis, disease stratification, treatment monitoring, prognostic assessment, and understanding of the pathogenesis of vascular infections.
Detailed description
Vascular infections encompass a heterogeneous group of severe infectious diseases involving the arterial wall, vascular grafts, or endografts, including infectious aortitis, infected arterial aneurysms, vascular graft and endograft infections, and fistula-associated vascular infections. These conditions are associated with substantial morbidity and mortality and remain challenging with respect to etiological diagnosis, assessment of disease activity, therapeutic decision-making, and prediction of recurrence and long-term outcomes.
The CAIGIS Cohort is an ambispective observational cohort established at Zhongshan Hospital, Fudan University. The study is designed as a longitudinal clinical research platform integrating standardized clinical data, microbiological investigations, molecular diagnostics, imaging, treatment information, outcome assessment, and longitudinal biospecimen collection. Patients with suspected or confirmed vascular infections will be included and followed longitudinally. In addition to characterization of the overall disease spectrum, the cohort will serve as a platform for multiple nested diagnostic, prognostic, microbiological, imaging, and translational studies.
Etiological diagnosis and evaluation of diagnostic technologies constitute a major focus of the cohort. Conventional microbiological methods, including blood culture, operative specimen culture, histopathology, and pathogen-specific serological testing, will be evaluated together with emerging molecular diagnostic technologies. Particular attention will be given to blood-based pathogen detection as a form of liquid biopsy, including metagenomic and targeted sequencing approaches where available. Diagnostic yield, incremental diagnostic value, time to etiological diagnosis, concordance between blood and local-site specimens, and the clinical impact of different diagnostic strategies will be investigated. Operative tissue and prosthetic material, when available, will provide an important reference for evaluating blood-based diagnostic approaches.
The cohort will also investigate dynamic biomarkers for disease activity and prognosis. Serial blood samples obtained during diagnosis, treatment, and follow-up may be used to characterize changes in pathogen-derived signals and host-response biomarkers. Their associations with microbiological clearance, treatment response, persistent infection, recurrence, reoperation, and mortality will be explored. The long-term objective is to develop integrated diagnostic and prognostic models combining clinical, microbiological, molecular, imaging, and host-response information.
A further research focus is the role of 18F-FDG PET/CT and other imaging modalities in both diagnosis and longitudinal monitoring. The diagnostic performance and incremental value of PET/CT, particularly in patients with inconclusive conventional imaging, will be evaluated. Where serial PET/CT examinations are clinically available, changes in metabolic activity and imaging patterns will be studied in relation to treatment response, residual infection, recurrence, and prognosis. Quantitative and semi-quantitative imaging parameters may be integrated with microbiological and biomarker data to investigate whether multimodal assessment can improve disease classification and therapeutic monitoring.
Fistula-associated vascular infection, particularly vascular-enteric fistula-associated infection, represents another key area of investigation. These patients often demonstrate complex polymicrobial patterns and may undergo substantial changes in microbial composition during antimicrobial treatment, surgery, and postoperative recovery. Serial blood, operative tissue, fistula-adjacent specimens, and other clinically obtained samples may therefore be used to characterize the longitudinal dynamics of microbial communities, distinguish vascular pathogens from enteric-source organisms, and explore the relationship between microbial composition, fistula status, treatment strategy, and clinical outcome.
The cohort will also support pathogen-specific translational studies. For Candida species, research will focus on distinguishing colonization or contamination from clinically significant invasive vascular infection and identifying microbiological, imaging, host, and clinical features associated with invasive disease and adverse outcomes. For mycobacterial vascular infections, including infections caused by Mycobacterium tuberculosis and nontuberculous mycobacteria, studies will investigate clinical characteristics, diagnostic features, microbial determinants, host susceptibility, and potential mechanisms underlying vascular tropism and persistent infection.
In patients undergoing surgery, infected vascular tissues and prosthetic materials may additionally be used to investigate in situ pathogen-host interactions. These studies may examine the spatial distribution of pathogens within infected tissue, local inflammatory and immune responses, tissue injury, and the relationship between microbial localization and pathological phenotype. Depending on specimen availability and individual nested study protocols, approaches may include microbiological, histopathological, molecular, genomic, transcriptomic, and spatial analyses.
Through the integration of clinical phenotyping, longitudinal biospecimen collection, pathogen-oriented diagnostics, liquid biopsy, molecular imaging, prognostic biomarkers, and translational investigation, the CAIGIS Cohort aims to establish a comprehensive research infrastructure for vascular infections. The overarching goal is to improve etiological diagnosis, disease stratification, treatment monitoring, prognostic assessment, and mechanistic understanding of these complex infections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Vascular Infections | – | –Patients with suspected or confirmed vascular infections, including infectious aortitis, infected arterial aneurysms, vascular graft or endograft infections, and fistula-associated vascular infections. Clinical, microbiological, molecular diagnostic, imaging, treatment, outcome, and biospecimen data will be collected longitudinally to support diagnostic, prognostic, and translational studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of consecutive adult patients evaluated or treated at Zhongshan Hospital, Fudan University, for suspected or confirmed vascular infections involving the native arterial wall, vascular grafts, or endografts. The cohort includes infectious aortitis, infected arterial aneurysms, vascular graft or endograft infections, and fistula-associated vascular infections. The ambispective design includes retrospectively identified patients with adequate clinical records and prospectively enrolled patients undergoing longitudinal follow-up. Clinical, microbiological, imaging, treatment, and outcome data will be collected, and biospecimens will be retained when available. Final diagnostic classification will be determined by multidisciplinary adjudication integrating clinical presentation, microbiological and molecular findings, imaging, pathology, operative findings, and longitudinal clinical course.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Patients with suspected or confirmed vascular infection involving the native arterial wall, vascular graft, or endograft, including but not limited to infectious aortitis, infected arterial aneurysm, vascular graft or endograft infection, and fistula-associated vascular infection.
- Patients evaluated or treated at Zhongshan Hospital, Fudan University, with sufficient clinical information to allow diagnostic adjudication and outcome assessment.
- For the prospective cohort, willingness to participate and provide informed consent when required.
- For the retrospective cohort, availability of relevant clinical records meeting the requirements approved by the institutional ethics committee.
Key exclusion criteria (3 listed)
- Isolated superficial surgical-site infection without evidence of involvement of the arterial wall, vascular graft, or endograft.
- Insufficient clinical data to permit diagnostic adjudication or longitudinal outcome assessment.
- Refusal to participate in the prospective component when informed consent is required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sustained Cure Rate One Year After Discontinuation of Antimicrobial Therapy
Time frame: 1 year after discontinuation of antimicrobial therapy
Proportion of participants who remain alive and free from persistent or recurrent vascular infection for 1 year after discontinuation of antimicrobial therapy, without reinitiation of antimicrobial treatment for the index vascular infection or unplanned infection-related surgical or endovascular intervention.
Five-Year All-Cause Mortality
Time frame: 5 years after the index diagnosis
Proportion of participants who die from any cause within 5 years after the index diagnosis of vascular infection.
2 secondary outcomes
Proportion of Patients Requiring Lifelong Suppressive Antimicrobial Therapy
Time frame: Up to 2 years after diagnosis
Five-Year Infection-Related Mortality
Time frame: Up to 5 years after the index diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Results publication: PubMed 37601730Linder KA, Miceli MH. Impact of Metagenomic Next-Generation Sequencing of Plasma Cell-free DNA Testing in the Management of Patients With Suspected Infectious Diseases. Open Forum Infect Dis. 2023 Jul 24;10(8):ofad385. doi: 10.1093/ofid/ofad385. eCollection 2023 Aug.
- Results publication: PubMed 35376992Lauri C, Signore A, Glaudemans AWJM, Treglia G, Gheysens O, Slart RHJA, Iezzi R, Prakken NHJ, Debus ES, Honig S, Lejay A, Chakfe N. Evidence-based guideline of the European Association of Nuclear Medicine (EANM) on imaging infection in vascular grafts. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3430-3451. doi: 10.1007/s00259-022-05769-x. Epub 2022 Apr 4.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 34140225Anagnostopoulos A, Mayer F, Ledergerber B, Bergada-Pijuan J, Husmann L, Mestres CA, Rancic Z, Hasse B; VASGRA Cohort Study. Editor's Choice - Validation of the Management of Aortic Graft Infection Collaboration (MAGIC) Criteria for the Diagnosis of Vascular Graft/Endograft Infection: Results from the Prospective Vascular Graft Cohort Study. Eur J Vasc Endovasc Surg. 2021 Aug;62(2):251-257. doi: 10.1016/j.ejvs.2021.05.010. Epub 2021 Jun 14.
- Results publication: PubMed 27771318Lyons OT, Baguneid M, Barwick TD, Bell RE, Foster N, Homer-Vanniasinkam S, Hopkins S, Hussain A, Katsanos K, Modarai B, Sandoe JA, Thomas S, Price NM. Diagnosis of Aortic Graft Infection: A Case Definition by the Management of Aortic Graft Infection Collaboration (MAGIC). Eur J Vasc Endovasc Surg. 2016 Dec;52(6):758-763. doi: 10.1016/j.ejvs.2016.09.007. Epub 2016 Oct 19.
- Results publication: PubMed 40744353Sorelius K, Verhoek R, Berard X, Lyons OTA, Puges M, Wyss TR; International Expert Panel on Vascular Graft and Endograft Infections; European Society for Vascular Surgery Clinical Practice Guidelines on the Management of Vascular Graft and Endograft Infections Writing Committee. Vascular Graft and Endograft Infections: A Delphi Consensus Document on Terminology, Definitions, Treatment, Outcomes, Follow Up, and Reporting Standards. Eur J Vasc Endovasc Surg. 2026 Mar;71(3):497-507. doi: 10.1016/j.ejvs.2025.07.044. Epub 2025 Jul 29.
- Results publication: PubMed 42448560Lejay A, Saleem BR, Barwick TD, Beck AW, Berard X, Eilenberg W, Gavali H, Hasse B, Heinola I, Lyons OT, Perini P, Puges M, Price NM, Sorelius K, Wouthuyzen-Bakker M, Wyss TR, Boyle J, Dias NV, van Herzeele I, Lepidi S, Mees BME, Resch T, Ribeiro TF, Trimarchi S, Wanhainen A, Chakfe N, Hernandez-Meneses M, Kahlberg A, Khashram M, Szeberin Z, Zeebregts C. Editor's Choice - European Society for Vascular Surgery (ESVS) 2026 Clinical Practice Guidelines on the Management of Vascular Graft and Endograft Infections. Eur J Vasc Endovasc Surg. 2026 Aug;72(2):227-293. doi: 10.1016/j.ejvs.2026.05.035. Epub 2026 Jul 14.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in peer-reviewed publications may be shared upon reasonable request. Data sharing will be subject to approval by the study investigators and relevant institutional or ethics committees, and will comply with applicable privacy, data protection, and regulatory requirements. Data containing potentially identifiable, genomic, or other sensitive information may be subject to additional restrictions.
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Prevention of Vascular Graft Infection With Hypochlorous Acid
Vascular Prosthetic Graft Infection
Active, not recruitingPhase 2
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
Chronic Myeloproliferative Disorders, Graft Versus Host Disease
RecruitingObservational study
Nosocomial Pneumonia After Coronary Artery Bypass Grafting
Coronary Artery Disease, Pneumonia Nosocomial
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.
Jianing Yue, MD, PhD contact
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 Vascular Graft Infection and Infectious Aortitis, run by Shanghai Zhongshan Hospital at 1 site in China.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing Miao, MD, PhD (+8613917763967, miao.qing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Cure Rate One Year After Discontinuation of Antimicrobial Therapy (time frame: 1 year after discontinuation of antimicrobial therapy). The study lists 2 primary outcomes in all. 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 NCT07847346, which also lists 8 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 2 Oct 2026.