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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| Main Authors: | , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2014
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| In: |
The journal of cardiovascular surgery
Year: 2014, Volume: 55, Issue: 4, Pages: 551-558 |
| ISSN: | 1827-191X |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://www.minervamedica.it/en/journals/cardiovascular-surgery/article.php?cod=R37Y2014N04A0551
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| Author Notes: | A. Schmidt, K. Keirse, E. Blessing, R. Langhoff, J. Diaz-Cartelle |
| Summary: | 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. |
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| Item Description: | Kein DOI vorhanden Gesehen am 16.09.2020 |
| Physical Description: | Online Resource |
| ISSN: | 1827-191X |