Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06951685

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

Led by Xeltis · Updated on 2025-07-15

6

Participants Needed

1

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 contrasted CT scan or previous angiogram up to 90 days before baseline
  • Patient has been informed of the study, agrees to its provisions, and has provided written informed consent
  • Patient agrees to pre- and post-procedure follow-up including angiography
  • Life expectancy of at least 24 months
Not Eligible

You will not qualify if you...

  • Requires or is scheduled for cardiac or another vascular surgical procedure within 30 days of the study procedure
  • Presence or history of bypass in the diseased limb
  • Requires sequential extremity revascularizations or other procedures needing additional vascular grafts
  • Stroke or myocardial infarction within 6 weeks or prior massive stroke with Modified Rankin Scale 3 or above
  • History of acute arterial occlusion needing emergent intervention
  • Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or on hemodialysis
  • Previous renal transplant
  • Uncontrolled arterial hypertension (BP >200 mmHg) on 2 successive readings
  • Uncontrolled or poorly controlled diabetes
  • Abnormal blood values affecting recovery or graft hemostasis
  • Reduced liver function defined by elevated bilirubin, INR >1.5, or prothrombin time >18 seconds
  • Any active local or systemic infection
  • Known heparin-induced thrombocytopenia
  • Known active bleeding disorder, coagulopathy, or thromboembolic disease
  • Allergies to device materials or study agents that cannot be controlled
  • Previous enrollment in this study
  • Participation in another study
  • Pregnant or breastfeeding, or woman in fertile period not using adequate contraception
  • Any condition that would prevent adequate safety and performance evaluation of the conduit
  • Intra-operative exclusion: unsuitable anatomy for XPAD conduit implantation such as smaller target vessel diameter or severe calcification

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centro de Investigación y Manejo del Cáncer (CIMCA)

San José, Costa Rica

Actively Recruiting

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Research Team

M

Methee Schreuder

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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