RecruitingNot ApplicableNCT06951685

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

Prospective, Non-randomized, Early Feasibility Clinical Study to Assess the Feasibility of the Novel Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit


Sponsor

Xeltis

Enrollment

6 participants

Start Date

May 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit for people with peripheral artery occlusive disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Centro de Investigación y Manejo del Cáncer (CIMCA)

San José, Costa Rica

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NCT06951685


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