RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
Summary
To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA). Long Balloon substudy: To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
Timeline
- Start
- 2017-03-02
- Primary completion
- 2019-11-18
- Completion
- 2023-10-25
Outcome
Met primary endpoint
registry analysis (superiority test); RANGER™ Paclitaxel Coated Balloon RCT vs Standard Balloon Angioplasty RCT; p = 0.0017; Risk Difference (RD) 0.166; Chi-squared NCT03064126 ↗
registry analysis (non-inferiority test); RANGER™ Paclitaxel Coated Balloon RCT vs Standard Balloon Angioplasty RCT; p <0.0001; Risk Difference (RD) 0.106; Chi-squared NCT03064126 ↗
paper Ranger DCB was superior to PTA (82.9% [n = 194 of 234] vs. 66.3% [n = 57 of 86]) PMID 34016410 ↗
paper Noninferior freedom from major adverse events (94.1% [n = 241 of 256] vs. 83.5% [n = 76 of 91]) was demonstrated PMID 34016410 ↗
Publications
- Background Litsky J, Chanda A, Stilp E, Lansky A, Mena C. Critical evaluation of stents in the peripheral arterial disease of the superficial femoral artery - focus on the paclitaxel eluting stent. Med Devices (Auckl). 2014 May 28;7:149-56. doi: 10.2147/MDER.S45472. eCollection 2014.
- Background Kakkar AM, Abbott JD. Percutaneous versus surgical management of lower extremity peripheral artery disease. Curr Atheroscler Rep. 2015;17(2):479. doi: 10.1007/s11883-014-0479-0.
- Background Razavi MK, Mustapha JA, Miller LE. Contemporary systematic review and meta-analysis of early outcomes with percutaneous treatment for infrapopliteal atherosclerotic disease. J Vasc Interv Radiol. 2014 Oct;25(10):1489-96, 1496.e1-3. doi: 10.1016/j.jvir.2014.06.018. Epub 2014 Aug 15.
- Background Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.
- Background Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.
- Schroe H, Sachar R, Keirse K, Soga Y, Brodmann M, Rao V, Werner M, Holden A, Lopez L, Krishnan P, Diaz-Cartelle J. The RANGER II superficial femoral artery trial: 1-year results of the long lesion cohort. Vasc Med. 2022 Oct;27(5):457-465. doi: 10.1177/1358863X221097164. Epub 2022 Aug 9.
- Soga Y, Fujihara M, Yamamoto Y, Nakamura S, Iida O, Kawasaki D, Urasawa K, Ando H, Mori S, Suzuki K, Horie K, Diaz-Cartelle J, Kozuki A. One-year results for Japanese patients in RANGER II SFA. Heart Vessels. 2022 Apr;37(4):568-573. doi: 10.1007/s00380-021-01947-3. Epub 2021 Sep 23.
- Sachar R, Soga Y, Ansari MM, Kozuki A, Lopez L, Brodmann M, Schroe H, Ramanath VS, Diaz-Cartelle J, Zeller T; RANGER II SFA Investigators. 1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon. JACC Cardiovasc Interv. 2021 May 24;14(10):1123-1133. doi: 10.1016/j.jcin.2021.03.021.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | — | — |