News | Peripheral Artery Disease (PAD) | July 02, 2018

PQ Bypass Effective in Treating Extremely Long SFA Lesions at 12 Months

DETOUR I trial presented during SVS Vascular Annual Meeting 2018 late breaking clinical trial session

PQ Bypass Effective in Treating Extremely Long SFA Lesions at 12 Months

July 2, 2018 — The PQ Bypass Detour System showed promising 12-month durability for patients with extremely long blockages in the superficial femoral artery (SFA) in new results from the DETOUR I Trial. The data were presented as a late-breaking clinical trial session at the Society for Vascular Surgery (SVS) Vascular Annual Meeting, June 20-23 in Boston, Mass. The trial enrolled lesions longer and more complex than those typically studied in SFA clinical trials, with an average lesion length of 37cm, 100 percent TASC II C/D, 96 percent chronic total occlusions (CTO) and 81 percent with moderate-to-severe calcification.

The DETOUR I trial — a prospective, single-arm, multicenter, core lab-adjudicated study — enrolled and treated 77 patients and 81 lesions. Primary and primary-assisted patency at 12 months in all lesions of the DETOUR I trial was 73 percent and 80 percent, respectively. Secondary patency was achieved in 94 percent of patients. Additional safety and effectiveness outcomes include 100 percent freedom from amputation, 99 percent freedom from acute limb ischemia, and Rutherford improvement of ≥ 2 classes in 90 percent of patients.

“The lesions treated in DETOUR I were more than just long, they were extremely long, completely blocked and severely calcified,” said Dainis Krieviņš, M.D., Ph.D., vascular surgeon and director of the Institute of Research at Pauls Stradins Clinical University Hospital, Riga, Latvia. “Endovascular devices currently approved for use on these incredibly challenging lesions have surprisingly low durability in lesions that are half the size of the average DETOUR lesion and fail approximately 40 percent of the time by the 12-month milestone. This truly highlights the need for the minimally invasive DETOUR procedure for long, complex SFA lesions.”

Percutaneous femoropopliteal bypass (the Detour procedure) is an entirely new procedure enabled by PQ Bypass’s proprietary Detour System. The Detour procedure creates a pathway with PQ Bypass’s proprietary stent grafts, originating in the SFA, traveling through the femoral vein and ending in the popliteal artery, bypassing the diseased part of the artery. The stent grafts redirect oxygen-rich blood around the blockage, restoring blood flow to the lower leg and foot of the patient.

For more information: www.pqbypass.com

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init