XPAD European Feasibility Study
20. juli 2026 oppdatert av: Xeltis
Prospective, Non-randomized, European Feasibility Clinical Study to Assess the Safety and Performance of the Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit.
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
15
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sandra Kohler
- Telefonnummer: +31 (0) 6 55 55 57 14
- E-post: sandra.kohler@xeltis.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: XPAD
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary patency rate
Tidsramme: 12 months post-implant
|
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
Tidsramme: Day 1, 30 days, 6 months, and 12 months post-implant
|
Day 1, 30 days, 6 months, and 12 months post-implant
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Implantation success rate
Tidsramme: Day 1
|
Implantation success defined as a technically successful XPAD conduit implantation in the planned configuration, free from kinking and tension in the anastomoses, and a patent XPAD conduit at the moment of discharge.
|
Day 1
|
|
Freedom from Major Bleeding events
Tidsramme: Day 1, 30 days and 6 months post-implant
|
Major Bleeding defined as type 3, 4 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) classifications
|
Day 1, 30 days and 6 months post-implant
|
|
Patency (primary, primary assisted, and secondary) rates
Tidsramme: 6, 12, 24, 36, 48 and 60 months post-implant
|
Primary patency defined as the interval between conduit implantation and the first intervention to maintain or restore patency. Assisted primary patency defined as the interval between conduit implantation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality the conduit. Secondary patency defined as the interval between conduit implantation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the conduit, including occurrence of a censored event (death, change of modality, loss of follow-up). |
6, 12, 24, 36, 48 and 60 months post-implant
|
|
Freedom from device-related SAE
Tidsramme: 24, 36, 48 and 60 months post-implant
|
24, 36, 48 and 60 months post-implant
|
|
|
Rate of wound/conduit infections
Tidsramme: 30 days, 6, 12, 24, 36, 48 and 60 months post-implant
|
30 days, 6, 12, 24, 36, 48 and 60 months post-implant
|
|
|
Freedom from Major Amputations
Tidsramme: 30 days, 6, 12, 24, 36, 48, and 60 months post-implant
|
Major Amputation defined as any amputation that results in limb shortening
|
30 days, 6, 12, 24, 36, 48, and 60 months post-implant
|
|
Freedom from all-cause mortality
Tidsramme: 30 days, 6, 12, 24, 36, 48, and 60 months post-implant
|
30 days, 6, 12, 24, 36, 48, and 60 months post-implant
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
1. desember 2026
Primær fullføring (Antatt)
1. desember 2028
Studiet fullført (Antatt)
1. desember 2032
Datoer for studieregistrering
Først innsendt
15. juli 2026
Først innsendt som oppfylte QC-kriteriene
20. juli 2026
Først lagt ut (Faktiske)
21. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- XEL-CR-17
Plan for individuelle deltakerdata (IPD)
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NEI
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