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

NCT06951685 | Recruiting

• 1 other identifier: XEL-CR-15
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Artery Occlusive Disease

Outcome Measures

Primary Outcomes (2)

• Primary patency rate

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

  12 months

• Freedom from device-related SAE

  Day 1, 1, 6 and 12 months

Secondary Outcomes (7)

• Implantation success rate

  Day 1

• Freedom from Major Bleeding events

  Day 1, 1 and 6 months

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

  6, 12, 24, and 36 months

• Freedom from device-related SAE

  24 and 36 months

• Rate of wound/graft infections

  1, 6, 12, 24, and 36 months

Study Arms (1)

XPAD Bypass Conduit

EXPERIMENTAL

Device: Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit

Interventions

Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit DEVICE

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.

XPAD Bypass Conduit

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Xeltis: lead

Study Sites (1)

Centro de Investigación y Manejo del Cáncer (CIMCA)

San José, Costa Rica

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Central Study Contacts

Methee Schreuder

CONTACT

+31 40 751 7614; clinical@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: April 11, 2025
• First Posted: April 30, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

CO (1)