Peripheral Arterial DiseaseNCT07716020
XPAD European Feasibility Study
A study testing XPAD conduit in people with Peripheral Arterial Disease, run by Xeltis.
Trial summary
A prospective, single arm, non-randomized European feasibility study to evaluate the safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective lower-limb, above or below the knee, bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- XPAD conduit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2032
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with peripheral artery occlusion who require elective lower-limb bypass surgery
- Participant has Rutherford grade 3 or 4 occlusive vascular disease and TASC C or D lesions.
- At least 18 years of age at screening
- Suitable anatomy while avoiding joints (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
- Participant has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
- Participant has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography
- Life expectancy of at least 24 months
Who cannot join
- Participant requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
- Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)
- History of acute arterial occlusion requiring an emergent intervention within the last 12 months
- Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or undergoing hemodialysis
- Previous renal transplant
- Uncontrolled arterial hypertension (BP >200 mmHg) at 2 successive readings
Show all 18Show fewer
- Uncontrolled or poorly controlled diabetes
- Abnormal blood values that could influence participant recovery and or/ graft hemostasis
- Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) >1.5 or prothrombin time (PT) >18 seconds
- Any active local or systemic infection
- Known heparin- induced thrombocytopenia, active bleeding disorder and/or any coagulopathy or thromboembolic disease
- Allergies to study device (nitinol) or agents/medication, such as contrast agents, aspirin or NOACs, that can't be controlled medically
- Previous enrolment in this study
- Participant is participating in another study
- Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit
- Intra-operative exclusion criteria:
- 1. Unsuitable anatomy to implant the XPAD conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Non-randomized, European Feasibility Clinical Study to Assess the Safety and Performance of the Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit.
A prospective, single arm, non-randomized European feasibility study to evaluate the safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective lower-limb, above or below the knee, bypass surgery.
- Conditions
- Peripheral Arterial Disease
- Being tested
- XPAD conduit
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPAD conduitDevice
The XPAD bypass conduit is a sterile, restorative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 33cm length and 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The XPAD conduit is in a straight configuration and may be implanted in the lower limb for elective bypass surgery.
| Study group | Role | What they receive |
|---|---|---|
| XPAD | Experimental | Not described Receives: Device: XPAD conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate
Primary patency defined as the interval between conduit implantation and the first intervention to maintain or restore patency
Measured: 12 months post-implant
Freedom from device-related SAE
Measured: Day 1, 30 days, 6 months, and 12 months post-implant
Secondary outcomes (7)
Implantation success rate
Implantation success defined as a technically successful XPAD conduit implantation in the planned configuration, free from kinking and tension in the anastomoses, and a patent XPAD conduit at the moment of discharge.
Measured: Day 1
Freedom from Major Bleeding events
Major Bleeding defined as type 3, 4 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) classifications
Measured: Day 1, 30 days and 6 months post-implant
Patency (primary, primary assisted, and secondary) rates
Primary patency defined as the interval between conduit implantation and the first intervention to maintain or restore patency.
Assisted primary patency defined as the interval between conduit implantation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality the conduit.
Secondary patency defined as the interval between conduit implantation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the conduit, including occurrence of a censored event (death, change of modality, loss of follow-up).
Measured: 6, 12, 24, 36, 48 and 60 months post-implant
Freedom from device-related SAE
Measured: 24, 36, 48 and 60 months post-implant
Rate of wound/conduit infections
Measured: 30 days, 6, 12, 24, 36, 48 and 60 months post-implant
Freedom from Major Amputations
Major Amputation defined as any amputation that results in limb shortening
Measured: 30 days, 6, 12, 24, 36, 48, and 60 months post-implant
Freedom from all-cause mortality
Measured: 30 days, 6, 12, 24, 36, 48, and 60 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xeltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716020
- Sponsor's protocol ID
- XEL-CR-17
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized, European Feasibility Clinical Study to Assess the Safety and Performance of the Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit.
- ClinicalTrials.gov ID
- NCT07716020
- Acronym / sponsor ID
- XEL-CR-17
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 21 Jul 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.
A prospective, single arm, non-randomized European feasibility study to evaluate the safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective lower-limb, above or below the knee, bypass surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XPAD | Experimental | Device: XPAD conduit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with peripheral artery occlusion who require elective lower-limb bypass surgery
- Participant has Rutherford grade 3 or 4 occlusive vascular disease and TASC C or D lesions.
- At least 18 years of age at screening
- Suitable anatomy while avoiding joints (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
- Participant has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
Key exclusion criteria (18 listed)
- Participant requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
- Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)
- History of acute arterial occlusion requiring an emergent intervention within the last 12 months
- Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or undergoing hemodialysis
- Previous renal transplant
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 |
|---|---|---|
| XPAD conduitThe XPAD bypass conduit is a sterile, restorative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 33cm length and 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The XPAD conduit is in a straight configuration and may be implanted in the lower limb for elective bypass surgery. | Device | XPAD |
Primary outcome
Primary patency rate
Time frame: 12 months post-implant
Primary patency defined as the interval between conduit implantation and the first intervention to maintain or restore patency
Freedom from device-related SAE
Time frame: Day 1, 30 days, 6 months, and 12 months post-implant
7 secondary outcomes
Implantation success rate
Time frame: Day 1
Freedom from Major Bleeding events
Time frame: Day 1, 30 days and 6 months post-implant
Patency (primary, primary assisted, and secondary) rates
Time frame: 6, 12, 24, 36, 48 and 60 months post-implant
Freedom from device-related SAE
Time frame: 24, 36, 48 and 60 months post-implant
Rate of wound/conduit infections
Time frame: 30 days, 6, 12, 24, 36, 48 and 60 months post-implant
Freedom from Major Amputations
Time frame: 30 days, 6, 12, 24, 36, 48, and 60 months post-implant
Freedom from all-cause mortality
Time frame: 30 days, 6, 12, 24, 36, 48, and 60 months post-implant
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 21 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing XPAD conduit in people with Peripheral Arterial Disease, run by Xeltis.
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 7 inclusion and 18 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: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sandra Kohler (+31 (0) 6 55 55 57 14, sandra.kohler@xeltis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate (time frame: 12 months post-implant). 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?
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 21 Jul 2026.