Offroad re-entry catheter system for subintimal recanalization of chronic total occlusions in femoropopliteal arteries

• Verfasst von: Schmidt, Andrej [VerfasserIn]
• Verfasst von: Keirse, K. [VerfasserIn]
• Verfasst von: Blessing, Erwin [VerfasserIn]
• Verfasst von: Langhoff, R. [VerfasserIn]
• Verfasst von: Diaz-Cartelle, J. [VerfasserIn]
• Titel: Offroad re-entry catheter system for subintimal recanalization of chronic total occlusions in femoropopliteal arteries
• Titelzusatz: primary safety and effectiveness results of the re-route trial
• Verf.angabe: A. Schmidt, K. Keirse, E. Blessing, R. Langhoff, J. Diaz-Cartelle
• Jahr: 2014
• Umfang: 8 S.
• Fussnoten: Kein DOI vorhanden ; Gesehen am 16.09.2020
• Titel Quelle: Enthalten in: The journal of cardiovascular surgery
• Ort Quelle: Torino : Ed. Minerva Medica, 1998
• Jahr Quelle: 2014
• Band/Heft Quelle: 55(2014), 4, Seite 551-558
• ISSN Quelle: 1827-191X
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Aged
• Sach-SW: Female
• Sach-SW: Humans
• Sach-SW: Male
• Sach-SW: Aged, 80 and over
• Sach-SW: Amputation
• Sach-SW: Catheterization, Peripheral
• Sach-SW: Chronic Disease
• Sach-SW: Constriction, Pathologic
• Sach-SW: Endovascular Procedures
• Sach-SW: Equipment Design
• Sach-SW: Europe
• Sach-SW: Femoral Artery
• Sach-SW: Intermittent Claudication
• Sach-SW: Ischemia
• Sach-SW: Limb Salvage
• Sach-SW: Middle Aged
• Sach-SW: Peripheral Arterial Disease
• Sach-SW: Popliteal Artery
• Sach-SW: Product Surveillance, Postmarketing
• Sach-SW: Prospective Studies
• Sach-SW: Radiography
• Sach-SW: Time Factors
• Sach-SW: Treatment Outcome
• Sach-SW: Vascular Access Devices
• Sach-SW: Vascular Patency
• K10plus-PPN: 1733107827

Abstract

AIM: Aim of the study was to provide additional clinical data regarding the safety and technical success of the OffRoad Re-Entry Catheter System (Boston Scientific, Natick, MA, USA) for subintimal recanalization of chronic total occlusions (CTO) in the femoropopliteal arteries. - METHODS: A total of 92 patients (mean age 70.3±10.6 years; 70% male) were enrolled in this prospective, single-arm, post-market study conducted at 12 European centers. Patients were required to have claudication or critical limb ischemia and a CTO lesion in a native femoropopliteal artery. The primary safety endpoint was the composite rate of device-related major adverse events (MAEs; i.e., death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation of the treated lower limb) at 30 days. Effectiveness was based on device technical success, defined as placement of a guidewire in the true lumen distal to a CTO. - RESULTS: Ninety patients were evaluable for the primary safety endpoint. The 30-day device-related MAE rate was 3.3% (3/90), with an upper confidence bound of 6.5%, which was lower than the prespecified performance goal of 15%. All 3 events were clinically significant peripheral emboli. Technical success was 84.8% (78/92) with a lower confidence bound of 78.6%, which exceeded the prespecified performance goal of 76%. A decrease of ≥1 Rutherford category was observed in 75% (65/87) of patients at the 30 day visit. - CONCLUSION: The Re-ROUTE trial results demonstrate acceptable performance of the OffRoad system in terms of safety and technical success for the recanalization of femoropopliteal CTOs.