Peripheral Artery Occlusive DiseaseNCT06951685
Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study
A study testing Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit in people with Peripheral Artery Occlusive Disease, run by Xeltis at 1 site in Costa Rica.
Trial summary
A prospective, single arm, non-randomized early feasibility study to evaluate the preliminary safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective above-knee femoral popliteal bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Occlusive Disease
- What is being tested?
- Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCosta Rica
- Study dates
- 2 May 2025to Dec 2028
- 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
- Subjects with femoral artery occlusion who require elective above-knee femoral popliteal bypass surgery
- Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease and TASC C or D lesions. Rutherford grade 5 may be included with a wound, ischemia and foot infection (WiFi) classification of up to grade 2, provided there are two outflow vessels with at least one reaching the pedal arch
- At least 18 years of age at screening
- Suitable anatomy (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
- Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
- Patient 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
- Subject requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
- Presence or history of bypass in the diseased limb
- Subject requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts
- 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
- Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or undergoing hemodialysis
Show all 21Show fewer
- Previous renal transplant
- Uncontrolled arterial hypertension (BP >200 mmHg) at 2 successive readings
- Uncontrolled or poorly controlled diabetes
- Abnormal blood values that could influence patient 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
- Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
- Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
- Previous enrolment in this study
- Subject 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
1 site in 1 country.
Costa Rica1 site
Centro de Investigación y Manejo del Cáncer (CIMCA)
San José
About this study
Official title: Prospective, Non-randomized, Early Feasibility Clinical Study to Assess the Feasibility of the Novel Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
A prospective, single arm, non-randomized early feasibility study to evaluate the preliminary safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective above-knee femoral popliteal bypass surgery.
- Conditions
- Peripheral Artery Occlusive Disease
- Being tested
- Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeltis Peripheral Artery Disease (XPAD) Bypass ConduitDevice
The XPAD bypass conduit is a sterile, restorative biodegradable polymer-based vascular graft, 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 above the knee for elective femoral popliteal bypass surgery.
| Study group | Role | What they receive |
|---|---|---|
| XPAD Bypass Conduit | Experimental | Not described Receives: Device: Xeltis Peripheral Artery Disease (XPAD) Bypass 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 graft implantation and the first intervention to maintain or restore patency
Measured: 12 months
Freedom from device-related SAE
Measured: Day 1, 1, 6 and 12 months
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, 1 and 6 months
Patency (primary, primary assisted, and secondary) rates
Primary patency: Defined as the interval between graft implantation and the first intervention to maintain or restore patency.
Assisted primary patency: Defined as the interval between graft implantation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality the graft.
Secondary patency: Defined as the interval between graft implantation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the graft, including occurrence of a censored event (death, change of modality, loss of follow-up)
Measured: 6, 12, 24, and 36 months
Freedom from device-related SAE
Measured: 24 and 36 months
Rate of wound/graft infections
Measured: 1, 6, 12, 24, and 36 months
Freedom from Major Amputations
Major Amputation: Defined as any amputation that results in limb shortening
Measured: 1, 6, 12, 24, and 36 months
Freedom from all-cause mortality
Measured: 1, 6, 12, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start2 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Occlusive 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xeltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951685
- Sponsor's protocol ID
- XEL-CR-15
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized, Early Feasibility Clinical Study to Assess the Feasibility of the Novel Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
- ClinicalTrials.gov ID
- NCT06951685
- Acronym / sponsor ID
- XEL-CR-15
- Conditions
- Peripheral Artery Occlusive Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Study start
- 2 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Apr 2025 (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 early feasibility study to evaluate the preliminary safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective above-knee femoral popliteal 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 Bypass Conduit | Experimental | Device: Xeltis Peripheral Artery Disease (XPAD) Bypass 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)
- Subjects with femoral artery occlusion who require elective above-knee femoral popliteal bypass surgery
- Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease and TASC C or D lesions. Rutherford grade 5 may be included with a wound, ischemia and foot infection (WiFi) classification of up to grade 2, provided there are two outflow vessels with at least one reaching the pedal arch
- At least 18 years of age at screening
- Suitable anatomy (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
- Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
Key exclusion criteria (21 listed)
- Subject requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
- Presence or history of bypass in the diseased limb
- Subject requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts
- 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
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 |
|---|---|---|
| Xeltis Peripheral Artery Disease (XPAD) Bypass ConduitThe XPAD bypass conduit is a sterile, restorative biodegradable polymer-based vascular graft, 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 above the knee for elective femoral popliteal bypass surgery. | Device | XPAD Bypass Conduit |
Primary outcome
Primary patency rate
Time frame: 12 months
Primary patency: Defined as the interval between graft implantation and the first intervention to maintain or restore patency
Freedom from device-related SAE
Time frame: Day 1, 1, 6 and 12 months
7 secondary outcomes
Implantation success rate
Time frame: Day 1
Freedom from Major Bleeding events
Time frame: Day 1, 1 and 6 months
Patency (primary, primary assisted, and secondary) rates
Time frame: 6, 12, 24, and 36 months
Freedom from device-related SAE
Time frame: 24 and 36 months
Rate of wound/graft infections
Time frame: 1, 6, 12, 24, and 36 months
Freedom from Major Amputations
Time frame: 1, 6, 12, 24, and 36 months
Freedom from all-cause mortality
Time frame: 1, 6, 12, 24, and 36 months
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 6 Oct 2026.
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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.
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 Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit in people with Peripheral Artery Occlusive Disease, run by Xeltis at 1 site in Costa Rica.
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 21 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 6 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 Costa Rica. 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 rate (time frame: 12 months). 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 6 Oct 2026.