Vascular DiseasesNCT03173703
Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular Repair
A study testing Implant the XenoSure patch, Repair/reconstruction of the diseased vessel and Implant the Vascular-Patch in people with Vascular Diseases, run by LeMaitre Vascular at 1 site in China.
Trial summary
The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Implant the XenoSure patch, Repair/reconstruction of the diseased vessel and Implant the Vascular-Patch
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2017to 15 Nov 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Any man or woman aged between 18~80 years old 2) The expected lifetime of no less than 12 months 3) The subject can be considered for suturing with XenoSure Biological Patch after the peripheral vascular repair surgery. The subject's targeted arterial diameter is less than 5mm or the arterial incision length is more than 4cm and less than 9cm.
- 4) Physical conditions and vital signs meet requirements for the surgery. 5) The subjects and/or their guardians sign the written Informed Consent Form.
Who cannot join
- Patients with severe visceral diseases in heart, liver, kidney, etc.
- Patients have unstable vital signs and not suitable for the surgery indications
- Patients need vascular outflow stenting repair in the same location with XenoSure® Biological Patch.
- Pregnant or lactating women
- Patients With severe allergic history (especially allergic to bovine materials)
- Patients with the past medical history of severe immunodeficiency disease
Show all 13Show fewer
- The subject has used or plans to use immunomodulatory drugs for more than half a year.
- The subject with poor blood clotting function is defined as that pre-operative INR or APTT is prolonged over 30% than the reference value without drug intervention, or that blood platelet count is less than 100*10^9/L.
- The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate [GRF]<30mL/min/1.73m2.
- The subject's ALT or AST level is 2.5 times higher than the upper normal limit or the subject has active liver disease or icterus.
- The subject has participated in another clinical study within 3 months or is participating in another clinical study now.
- The investigator believes that the subject has other reasons unsuitable for inclusion.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Random, Controlled, Single-blinded, Multi-center and Non-inferiority Clinical Study to Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular Repair
The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.
Read the detailed description
The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.
144 subjects for peripheral vascular repair, including respective 72 subjects for the trial group and the control group.
- Conditions
- Vascular Diseases
- Being tested
- Implant the XenoSure patch, Repair/reconstruction of the diseased vessel, Implant the Vascular-Patch
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant the XenoSure patchDevice
The LeMaitre XenoSure patch will be used when close the repaired vessel
Repair/reconstruction of the diseased vesselProcedure or surgery
The diseased vessel is surgically repaired such as removing the clots.
Implant the Vascular-PatchDevice
The B. Braun Vascular-Patch will be used when close the repaired vessel
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | Test Arm are subjects to be implanted with test article -XenoSure patch. The interventions include: Repair/reconstruction of the diseased vessel; Implant the XenoSure patch Receives: Device: Implant the XenoSure patch; Procedure: Repair/reconstruction of the diseased vessel |
| Control Arm | Active comparator | Test Arm are subjects to be implanted with B. Braun's Vascular-Patch.The interventions include: Repair/reconstruction of the diseased vessel; Implant the Vascular-Patch. Receives: Procedure: Repair/reconstruction of the diseased vessel; Device: Implant the Vascular-Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency measured by ultrasound
The treated vessel is considered "patent" if the re-narrowing of the ID of the vessel is less than 20% of the ID that measured immediately after procedure. The study is considered achieved its primary endpoint if the primary patency rate of test device is non-inferior to the rate of the comparator device.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start13 Jul 2017
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LeMaitre Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173703
- Sponsor's protocol ID
- P15077-2
- Status last verified
- Mar 2025
- First submitted
- 25 May 2017
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random, Controlled, Single-blinded, Multi-center and Non-inferiority Clinical Study to Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular Repair
- ClinicalTrials.gov ID
- NCT03173703
- Acronym / sponsor ID
- P15077-2
- Conditions
- Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- LeMaitre VascularIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 2 Jun 2017 (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.
The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.
Detailed description
The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.
144 subjects for peripheral vascular repair, including respective 72 subjects for the trial group and the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Device: Implant the XenoSure patch, Procedure: Repair/reconstruction of the diseased vesselTest Arm are subjects to be implanted with test article -XenoSure patch. The interventions include: Repair/reconstruction of the diseased vessel; Implant the XenoSure patch |
| Control Arm | Active comparator | Procedure: Repair/reconstruction of the diseased vessel, Device: Implant the Vascular-PatchTest Arm are subjects to be implanted with B. Braun's Vascular-Patch.The interventions include: Repair/reconstruction of the diseased vessel; Implant the Vascular-Patch. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) Any man or woman aged between 18~80 years old 2) The expected lifetime of no less than 12 months 3) The subject can be considered for suturing with XenoSure Biological Patch after the peripheral vascular repair surgery. The subject's targeted arterial diameter is less than 5mm or the arterial incision length is more than 4cm and less than 9cm.
- 4) Physical conditions and vital signs meet requirements for the surgery. 5) The subjects and/or their guardians sign the written Informed Consent Form.
Key exclusion criteria (13 listed)
- Patients with severe visceral diseases in heart, liver, kidney, etc.
- Patients have unstable vital signs and not suitable for the surgery indications
- Patients need vascular outflow stenting repair in the same location with XenoSure® Biological Patch.
- Pregnant or lactating women
- Patients With severe allergic history (especially allergic to bovine materials)
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 |
|---|---|---|
| Implant the XenoSure patchThe LeMaitre XenoSure patch will be used when close the repaired vessel | Device | Test Arm |
| Repair/reconstruction of the diseased vesselThe diseased vessel is surgically repaired such as removing the clots. | Procedure or surgery | Control Arm, Test Arm |
| Implant the Vascular-PatchThe B. Braun Vascular-Patch will be used when close the repaired vessel | Device | Control Arm |
Primary outcome
Primary patency measured by ultrasound
Time frame: 6 months
The treated vessel is considered "patent" if the re-narrowing of the ID of the vessel is less than 20% of the ID that measured immediately after procedure. The study is considered achieved its primary endpoint if the primary patency rate of test device is non-inferior to the rate of the comparator device.
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 10 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Vascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant the XenoSure patch, Repair/reconstruction of the diseased vessel and Implant the Vascular-Patch in people with Vascular Diseases, run by LeMaitre Vascular 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 2 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2025. 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?
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?
Primary patency measured by ultrasound (time frame: 6 months). 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 10 Mar 2025.