Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study
© 2017 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. Objectives: The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB). Background: DCB coatings differ in excipients, paclitaxel dose, and coating...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Journal Article |
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2018
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| Online Access: | http://hdl.handle.net/20.500.11937/73398 |
| _version_ | 1848763003432861696 |
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| author | Schroë, H. Holden, A. Goueffic, Y. Jansen, Shirley Peeters, P. Keirse, K. Ito, W. Vermassen, F. Micari, A. Blessing, E. Jaff, M. Zeller, T. |
| author_facet | Schroë, H. Holden, A. Goueffic, Y. Jansen, Shirley Peeters, P. Keirse, K. Ito, W. Vermassen, F. Micari, A. Blessing, E. Jaff, M. Zeller, T. |
| author_sort | Schroë, H. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | © 2017 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. Objectives: The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB). Background: DCB coatings differ in excipients, paclitaxel dose, and coating morphologies. Due to these differences, a class effect with DCBs has not been demonstrated. Consequently, each DCB needs to be evaluated independently based on its own clinical study results. Methods: The ILLUMENATE Global Study is a prospective, multicenter, single-arm study. Patients with intermittent claudication or ischemic rest pain due to superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD) were treated with the Stellarex DCB. The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio =2.5 or clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety endpoint was freedom from device and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and CD-TLR through 12 months. Results: In total, 417 lesions were treated in 371 patients. The mean lesion length was 7.5 ± 5.3 cm, 40.8% of lesions were severely calcified per core laboratory fluoroscopy criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4% and the freedom from CD-TLR was 94.8% day 365 per Kaplan-Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline. Conclusions: This study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes. |
| first_indexed | 2025-11-14T10:56:33Z |
| format | Journal Article |
| id | curtin-20.500.11937-73398 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T10:56:33Z |
| publishDate | 2018 |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-733982018-12-13T09:35:40Z Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study Schroë, H. Holden, A. Goueffic, Y. Jansen, Shirley Peeters, P. Keirse, K. Ito, W. Vermassen, F. Micari, A. Blessing, E. Jaff, M. Zeller, T. © 2017 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. Objectives: The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB). Background: DCB coatings differ in excipients, paclitaxel dose, and coating morphologies. Due to these differences, a class effect with DCBs has not been demonstrated. Consequently, each DCB needs to be evaluated independently based on its own clinical study results. Methods: The ILLUMENATE Global Study is a prospective, multicenter, single-arm study. Patients with intermittent claudication or ischemic rest pain due to superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD) were treated with the Stellarex DCB. The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio =2.5 or clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety endpoint was freedom from device and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and CD-TLR through 12 months. Results: In total, 417 lesions were treated in 371 patients. The mean lesion length was 7.5 ± 5.3 cm, 40.8% of lesions were severely calcified per core laboratory fluoroscopy criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4% and the freedom from CD-TLR was 94.8% day 365 per Kaplan-Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline. Conclusions: This study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes. 2018 Journal Article http://hdl.handle.net/20.500.11937/73398 10.1002/ccd.27348 restricted |
| spellingShingle | Schroë, H. Holden, A. Goueffic, Y. Jansen, Shirley Peeters, P. Keirse, K. Ito, W. Vermassen, F. Micari, A. Blessing, E. Jaff, M. Zeller, T. Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study |
| title | Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study |
| title_full | Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study |
| title_fullStr | Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study |
| title_full_unstemmed | Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study |
| title_short | Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study |
| title_sort | stellarex drug-coated balloon for treatment of femoropopliteal arterial disease—the illumenate global study: 12-month results from a prospective, multicenter, single-arm study |
| url | http://hdl.handle.net/20.500.11937/73398 |