protocolSection identificationModule nctId: NCT06277362, orgStudyIdInfo id: CLTI012023, briefTitle: Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia, acronym: PiPER, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-01-31, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: EndoCore Lab s.r.l., class: OTHER, descriptionModule briefSummary: The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI., conditionsModule conditions: Peripheral Arterial Disease, conditions: Critical Limb-Threatening Ischemia, conditions: Diabetic Foot, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Safety Composite, secondaryOutcomes measure: Procedural Success, secondaryOutcomes measure: Primary Patency, secondaryOutcomes measure: Secondary Patency, secondaryOutcomes measure: A-V fistula flow rate, secondaryOutcomes measure: Minor amputation rates, secondaryOutcomes measure: Major amputation rates, secondaryOutcomes measure: Re-Treatment rate, secondaryOutcomes measure: Wound Size, secondaryOutcomes measure: TpcO2, secondaryOutcomes measure: WIFi class, secondaryOutcomes measure: Freedom from all cause death, secondaryOutcomes measure: Freedom from procedure-related death, secondaryOutcomes measure: Rutherford class, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Pederzoli, status: RECRUITING, city: Peschiera Del Garda, state: Veneto, zip: 37019, country: Italy, contacts name: Bruno Migliara, MD, role: CONTACT, email: bruno.migliara@gmail.com, geoPoint lat: 45.43912, lon: 10.68614, locations facility: Ospedale San Martino, status: NOT_YET_RECRUITING, city: Belluno, zip: 32100, country: Italy, contacts name: Luca Ferretto, MD, role: CONTACT, contacts name: Luca Ferretto, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.14262, lon: 12.2156, locations facility: Ospedale Bufalini, status: NOT_YET_RECRUITING, city: Cesena, zip: 47521, country: Italy, contacts name: Gabriele Testi, MD, role: CONTACT, contacts name: Gabriele Testi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.1391, lon: 12.24315, locations facility: Ospedale di Conegliano - USLL2, status: NOT_YET_RECRUITING, city: Conegliano, zip: 31015, country: Italy, contacts name: Massimo Corato, MD, role: CONTACT, contacts name: Massimo Corato, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.88805, lon: 12.30201, locations facility: Ospedale Cardarelli, status: NOT_YET_RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: Gianluca Cangiano, MD, role: CONTACT, contacts name: Gianluca Cangiano, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Arcispedale Santa Maria Nuova, status: NOT_YET_RECRUITING, city: Reggio Emilia, zip: 42122, country: Italy, contacts name: Antonio Fontana, MD, role: CONTACT, contacts name: Antonio Fontana, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Ospedale Santa Chiara, status: NOT_YET_RECRUITING, city: Trento, zip: 38123, country: Italy, contacts name: Stefano Bonvini, MD, role: CONTACT, contacts name: Stenano Bonvini, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.06787, lon: 11.12108, hasResults: False