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Offroad re-entry catheter system for subintimal recanalization of chronic total occlusions in femoropopliteal arteries: primary safety and effectiveness results of the re-route trial

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...

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Hauptverfasser: Schmidt, Andrej (VerfasserIn) , Keirse, K. (VerfasserIn) , Blessing, Erwin (VerfasserIn) , Langhoff, R. (VerfasserIn) , Diaz-Cartelle, J. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 2014
In: The journal of cardiovascular surgery
Year: 2014, Jahrgang: 55, Heft: 4, Pages: 551-558
ISSN:1827-191X
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://www.minervamedica.it/en/journals/cardiovascular-surgery/article.php?cod=R37Y2014N04A0551
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Verfasserangaben:A. Schmidt, K. Keirse, E. Blessing, R. Langhoff, J. Diaz-Cartelle

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520 |a 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. 
650 4 |a Aged 
650 4 |a Female 
650 4 |a Humans 
650 4 |a Male 
650 4 |a Aged, 80 and over 
650 4 |a Amputation 
650 4 |a Catheterization, Peripheral 
650 4 |a Chronic Disease 
650 4 |a Constriction, Pathologic 
650 4 |a Endovascular Procedures 
650 4 |a Equipment Design 
650 4 |a Europe 
650 4 |a Femoral Artery 
650 4 |a Intermittent Claudication 
650 4 |a Ischemia 
650 4 |a Limb Salvage 
650 4 |a Middle Aged 
650 4 |a Peripheral Arterial Disease 
650 4 |a Popliteal Artery 
650 4 |a Product Surveillance, Postmarketing 
650 4 |a Prospective Studies 
650 4 |a Radiography 
650 4 |a Time Factors 
650 4 |a Treatment Outcome 
650 4 |a Vascular Access Devices 
650 4 |a Vascular Patency 
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700 1 |a Langhoff, R.  |e VerfasserIn  |4 aut 
700 1 |a Diaz-Cartelle, J.  |e VerfasserIn  |4 aut 
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