News | Drug-Eluting Balloons | November 14, 2019

IN.PACT AV Access 6-Month Data Show Increased Vessel Patency

Trial showed drug-coated balloon had a 56 percent reduction in reinterventions

The IN.PACT Arteriovenous (AV) Access randomized trial evaluating the safety and effectiveness of the Medtronic IN.PACT AV Access drug-coated balloon (DCB) met both of its endpoints, in data presented at the 2019 Vascular Interventional Advances (VIVA) annual meeting. #VIVA #VIVA19 #VIVA2019

The IN.PACT Arteriovenous (AV) Access randomized trial evaluating the safety and effectiveness of the Medtronic IN.PACT AV Access drug-coated balloon (DCB) met both of its endpoints, in data presented at the 2019 Vascular Interventional Advances (VIVA) annual meeting.

 


November 7, 2019 — The IN.PACT Arteriovenous (AV) Access randomized trial evaluating the safety and effectiveness of the Medtronic IN.PACT AV Access drug-coated balloon (DCB) met both of its endpoints, in data presented at the 2019 Vascular Interventional Advances (VIVA) annual meeting.

The study compared the DCB to percutaneous transluminal angioplasty (PTA) for the treatment of 330 patients with obstructive lesions (de novo or restenotic) of the native arteriovenous dialysis fistulae (AVF) in the upper extremity. Target lesion primary patency was 81.4% in the DCB group compared to 59% in the PTA group (P < .001) and there was a 56% reduction in the total number of reinterventions required to maintain patency, explained Robert Lookstein, M.D., MHCDL, executive vice chairman in the Department of Diagnostic, Molecular and Interventioal Radiology, Mount Sinai Health System.

He said 12-month, all-cause mortality was 90.6% in the DCB group compared to 90.4% in the PTA group. The results were first presented at the CIRSE 2019 meeting. 

The trial was is an independently adjudicated, prospective, global, multicenter, single-blinded study. 

The primary effectiveness endpoint was the target lesion primary patency rate, defined as freedom from clinically driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through six months (210 days) post-procedure. The primary safety endpoint was defined as the serious adverse event rate involving the AV access circuit through 30 days post-procedure.

Distribution of lesion location, AVF type, and lesion type among patients in the DCB and PTA groups was similar (P=0.310, P=0.918, and P=0.905, respectively). Six-month primary patency of restenotic lesions was 78.9% in the DCB group compared to 52.4% in the PTA group (difference, 26.5%). Primary patency of radiocephalic fistulas was 81.7% in the DCB group compared to 60% in the PTA group (difference, 21.7%). Primary patency of brachiocephalic fistulas was 80.8% in the DCB group compared to 57.4% in the PTA group (difference, 23.4%). Primary patency of anastomotic lesions was 84.6% in the DCB group compared to 50.0% in the PTA group (difference, 34.6%). Primary patency of cephalic arch lesions was 84.0% in the DCB group compared to 50.0% in the PTA group (difference, 34%).

Find information on all the VIVA 2019 Late-breaking Clinical Trials
 

Related Content

News | Cath Lab

May 31, 2022 — Innovative Health, LLC, a specialty cardiology reprocessor, announced that the company has received ...

Home May 31, 2022
Home
News | Cath Lab

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

Home May 26, 2022
Home
News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
News | Cath Lab
April 18, 2022 – Royal Philips and Oulu University Hospital (Finland) have announced a strategic 10-year partnership ...
Home April 18, 2022
Home
News | Cath Lab
February 16, 2022 – Fremont Bank Foundation recently donated $750,000 to its community partner, St. Rose Hospital ...
Home February 16, 2022
Home
News | Cath Lab
February 14, 2022 — A collaborative effort between The Valley Heart and Vascular Institute’s cardiology team ...
Home February 14, 2022
Home
Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
News | Cath Lab

January 4, 2022 — The U.S. Food and Drug Administration (FDA) has authorized marketing of the first laser-based device ...

Home January 04, 2022
Home
News | Cath Lab

December 14, 2021 — RSIP Vision, a medical imaging company applying advanced artificial intelligence (AI) and computer ...

Home December 14, 2021
Home
Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
Subscribe Now