XPAD European Feasibility Study

NCT07716020 | Not Yet Recruiting

• 1 other identifier: XEL-CR-17
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Implantation success rate

  Day 1

• Freedom from Major Bleeding events

  Day 1, 30 days and 6 months post-implant

• Patency (primary, primary assisted, and secondary) rates

  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

Study Arms (1)

XPAD

EXPERIMENTAL

Device: XPAD conduit

Interventions

XPAD conduit DEVICE

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.

XPAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Xeltis: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Sandra Kohler

CONTACT

+31 (0) 6 55 55 57 14; sandra.kohler@xeltis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2032
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share