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Recruiting NCT06951685

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

No phase Interventional Peripheral Artery Occlusive Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit.
Who it may be relevant to
Registry conditions: Peripheral Artery Occlusive Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Costa Rica
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Xeltis 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.

Primary outcome measures

  • Primary patency rate [Time frame: 12 months]
  • Freedom from device-related SAE [Time frame: Day 1, 1, 6 and 12 months]
Secondary outcome measures (7)
  • Implantation success rate [Time frame: Day 1]
  • Freedom from Major Bleeding events [Time frame: Day 1, 1 and 6 months]
  • Patency (primary, primary assisted, and secondary) rates [Time frame: 6, 12, 24, and 36 months]
  • Freedom from device-related SAE [Time frame: 24 and 36 months]
  • Rate of wound/graft infections [Time frame: 1, 6, 12, 24, and 36 months]
  • Freedom from Major Amputations [Time frame: 1, 6, 12, 24, and 36 months]
  • Freedom from all-cause mortality [Time frame: 1, 6, 12, 24, and 36 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Previous enrolment in this study
  • Subject is participating in another study
  • Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Costa Rica · 1 center
  • Centro de Investigación y Manejo del Cáncer (CIMCA) — San José

Identifiers

NCT: NCT06951685 · XEL-CR-15

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗