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Active, not recruitingNCT06951685Updated Oct 6, 2026

Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study

An interventional study of Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit in Peripheral Artery Occlusive Disease, sponsored by Xeltis. Active, not recruiting at 1 site in Costa Rica. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Xeltis · Not applicable, Interventional, and Treatment

Updated Oct 6, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peripheral Artery Occlusive Disease
03

In context

Lead sponsor

Xeltis is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects with femoral artery occlusion who require elective above-knee femoral popliteal bypass surgery
  2. 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
  3. At least 18 years of age at screening
  4. Suitable anatomy (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
  5. Patient has been informed of the nature of the study, agrees to its provisions, and has provided written
  6. Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography
  7. of at least 24 months

Exclusion criteria

Exclusion Criteria:

  1. Subject requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
  2. Presence or history of bypass in the diseased limb
  3. Subject requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts
  4. Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)
  5. History of acute arterial occlusion requiring an emergent intervention
  6. Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or undergoing hemodialysis
  7. Previous renal transplant
  8. Uncontrolled arterial hypertension (BP >200 mmHg) at 2 successive readings
  9. Uncontrolled or poorly controlled diabetes
  10. Abnormal blood values that could influence patient recovery and or/ graft hemostasis
  11. Reduced liver function, defined as: >2x the for serum , (INR) >1.5 or prothrombin time (PT) >18 seconds
  12. Any active local or systemic infection
  13. Known heparin-induced thrombocytopenia
  14. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
  15. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
  16. Previous enrolment in this study
  17. Subject is participating in another study
  18. Pregnant or breastfeeding woman or woman in fertile period not taking adequate
  19. 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)

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    XPAD Bypass Conduit

    Device: Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit

Interventions

  • DeviceXeltis Peripheral Artery Disease (XPAD) Bypass Conduit

    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.

06

What researchers measure

Primary outcomes

  1. Primary patency rate

    Primary patency: Defined as the interval between graft implantation and the first intervention to maintain or restore patency

    Time frame: 12 months

  2. Freedom from device-related SAE

    Time frame: Day 1, 1, 6 and 12 months

Secondary outcomes

  1. 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

    Time frame: Day 1

  2. Freedom from Major Bleeding events

    Major Bleeding: Defined as type 3, 4 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) classifications

    Time frame: Day 1, 1 and 6 months

  3. 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)

    Time frame: 6, 12, 24, and 36 months

  4. Freedom from device-related SAE

    Time frame: 24 and 36 months

  5. Rate of wound/graft infections

    Time frame: 1, 6, 12, 24, and 36 months

  6. Freedom from Major Amputations

    Major Amputation: Defined as any amputation that results in limb shortening

    Time frame: 1, 6, 12, 24, and 36 months

  7. Freedom from all-cause mortality

    Time frame: 1, 6, 12, 24, and 36 months

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 6, 2026: primary completion Sep 2026 → Dec 2026 and completion Sep 2028 → Dec 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2025
First posted
Apr 30, 2025
StartActual
May 2, 2025
Primary completionEst.
Dec 2026was Sep 2026
CompletionEst.
Dec 2028was Sep 2028
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 6, 2026
Primary completion
Sep 2026→Dec 2026
Oct 6, 2026
Study completion
Sep 2028→Dec 2028
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Recruiting→Active, not recruiting
    Primary completion Sep 2026→Dec 2026
    Study completion Sep 2028→Dec 2028
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06951685
Lead sponsor
Xeltis
Responsible party
Sponsor
First posted
Apr 30, 2025
Start date
May 2, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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