XPAD European Feasibility Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: XPAD conduit

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra Kohler; Phone Number: +31 (0) 6 55 55 57 14; Email: sandra.kohler@xeltis.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants with peripheral artery occlusion who require elective lower-limb bypass surgery
2. Participant has Rutherford grade 3 or 4 occlusive vascular disease and TASC C or D lesions.
3. At least 18 years of age at screening
4. Suitable anatomy while avoiding joints (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
5. Participant has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
6. Participant has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography
7. Life expectancy of at least 24 months

Exclusion Criteria:

1. Participant requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
2. Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)
3. History of acute arterial occlusion requiring an emergent intervention within the last 12 months
4. Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or undergoing hemodialysis
5. Previous renal transplant
6. Uncontrolled arterial hypertension (BP >200 mmHg) at 2 successive readings
7. Uncontrolled or poorly controlled diabetes
8. Abnormal blood values that could influence participant recovery and or/ graft hemostasis
9. 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
10. Any active local or systemic infection
11. Known heparin- induced thrombocytopenia, active bleeding disorder and/or any coagulopathy or thromboembolic disease
12. Allergies to study device (nitinol) or agents/medication, such as contrast agents, aspirin or NOACs, that can't be controlled medically
13. Previous enrolment in this study
14. Participant is participating in another study
15. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
16. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: XPAD

Device: XPAD conduit; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency rate	Primary patency defined as the interval between conduit implantation and the first intervention to maintain or restore patency	12 months post-implant
Freedom from device-related SAE		Day 1, 30 days, 6 months, and 12 months post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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).	6, 12, 24, 36, 48 and 60 months post-implant
Freedom from device-related SAE		24, 36, 48 and 60 months post-implant
Rate of wound/conduit infections		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	30 days, 6, 12, 24, 36, 48, and 60 months post-implant
Freedom from all-cause mortality		30 days, 6, 12, 24, 36, 48, and 60 months post-implant

Collaborators and Investigators

• Sponsor: Xeltis

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: XEL-CR-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No