Treating stents, stent grafts and native vessel lesions in the SFA with Rotarex - 2 year results from the Prospective Multicenter Post Market Study

Sunday, March 30, 2025

3:54 PM – 4:03 PM CT

Location: Music City Center, 205 BC

Presenting Author(s)

Constantino Pena, MD

Clinical Associate Professor Radiology
Florida International Universirty and University of South Florida , United States

Author/Co-author(s)

ML

Michael Lichtenberg, MD, PhD

Chefarzt der Klinik für konservative und interventionelle Angiologie
Klinikum Hochsauerland., Germany

Purpose:

To evaluate the safety, technical performance and clinical benefits of the Rotarex Catheter for the treatment of arterial occlusions and sub-occlusions of stents, stent grafts or native vessel lesions in the SFA.

Materials and Methods: 220 patients were enrolled in a prospective, single-arm, multicenter study at 14 centers in Europe. Of those 220 patients, 66 had lesions in the SFA. The technical/procedural success, defined as the ability to cross and successfully treat the target lesion (angiographic residual stenosis < 50% with or without adjunctive treatments), was measured at completion of the index procedure. The safety endpoint, defined as freedom from major adverse events (MAEs), was collected through 30 days. The primary patency endpoint, collected at 1, 6, 12, and 24 months, was defined as freedom from clinically driven target lesion revascularization (TLR) and freedom from >50% stenosis (PSVR < 2.5). Secondary outcomes at 1, 6, 12, and 24-months included safety events; walking improvement (Vascu Quality of Life Questionnaire (VQ-6)); quality of life improvement (EQ5D 3L); and various sub-cohort analyses.

Results:

Technical success of Rotarex used alone was 47.0% and procedural success of Rotarex®S + an adjunctive treatment was 97.0%. Primary patency was 92.0% at 1 month, 72.9% at 6 months, 63.5% at 12 months and 54.0% at 24 months. Freedom from MAEs through 30 days was 100%. The MAE rate in the ITT population was 14.5% at 6 months, 27.5% at 12 months and 33.4% at 24 months. Freedom from TLR was 100% at 1 month, 86.9% at 6 months, 76.7% at 12 months and 74.1% at 24 months. Most subjects showed improvement in Rutherford Class at 1 month (84.1%), 6 months (91.1%), 12 months (96.1%) and 24 months (94.0%). Improvements were also observed in the quality-of-life measures.

Conclusion:

These results show that Rotarex is safe and effective for the treatment of arterial occlusions and sub-occlusions of stents, stent grafts or native vessel lesions in the SFA.