Use of the Peripheral Cutting Balloon to Treat Hemodialysis-related Stenoses
Section snippets
MATERIALS AND METHODS
This clinical trial was performed at 27 medical centers in the United States (Appendix 1). The investigational protocol was approved by the institutional review board at each medical center before patient enrollment. Informed consent was obtained after the nature of the procedure was described to each patient. This study was funded by Boston Scientific Corporation, Natick, MA.
Primary Endpoint
The primary endpoint for this clinical investigation was primary patency of the target lesion at 6 months. The initial comparative analysis of this endpoint combined the data from both patient groups, those with stenotic grafts and those with thrombosed grafts. In the 167 patients who underwent conventional PTA, the primary patency rates of the target lesions were 77.7%, 63.4%, and 40.5% at 1 month, 3 months, and 6 months, respectively. In the 173 patients who underwent treatment with the PCB,
DISCUSSION
The PCB was designed to decrease the local vascular trauma caused by conventional balloon angioplasty. In 1991, Barath and colleagues (7) described their experience with use of the cutting balloon in normal porcine arteries. By creating longitudinal incisions into the medial layer of the vascular wall while simultaneously dilating the lesion, the cutting balloon causes less stretching and less injury to the surrounding vascular smooth muscle. These investigators suggested that limiting the
APPENDIX: PRINCIPAL INVESTIGATORS AND SITES OF THE CLINICAL TRIAL
Jeff Siegel, MD, Vascular Access Center, Dallas TX; James Swischuk, MD, St. Francis Medical Center, Peoria, IL; Terry Reynolds, MD, Memorial Medical Center, Savannah, GA; John Ross, MD, Bamberg County Hospital, Bamberg, SC; Dennis Kay, MD, Ochsner Medical Foundation, New Orleans, LA; Rod Raabe, MD, Sacred Heart Medical Center, Spokane, WA; William Romano, MD, William Beaumont Hospital, Royal Oak, MI; Tony Smith, MD, Duke University Medical Center, Durham, NC; John Fischer, MD, St. Luke's
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2021, Annals of Vascular SurgeryCitation Excerpt :It also places a heavy burden on the health care system both in terms of financially and increased workload. Various available endovascular options include bare-metal stent (primary 6-month patency rate of 39.3%2), cutting balloon (primary 6-month patency rate at 47.9%3), and covered stent which enhances the 6-month primary patency rate of poly-tetra-flour-ethylene grafts to 51% after-stent graft implantation in venous outflow stenoses.4 Drug-coated balloons (DCB) for dialysis access show promising results in the Katsanos study with a 6-month primary patency of 70% in paclitaxel-coated balloon (DCB) versus 25% in plain old balloon angioplasty (POBA) [P = 0.001].5
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This study was funded by Boston Scientific Corporation, Natick, MA.