960
Participants
Start Date
October 20, 2023
Primary Completion Date
June 30, 2027
Study Completion Date
June 30, 2031
PCI with SELUTION SLR DCB
After target lesion pre-dilatation and preparation , a SELUTION SLR 014 PTCA DEB study device should be selected with nominal diameter equal to the RVD of the target lesion (1:1 ratio) and length that allows approximately 2.00 mm longer than the proximal and distal edges of the target lesion (defined as the proximal and distal extent of predilation). If IVUS is performed to assess RVD, and DEB upsizing is deemed clinically necessary for optimal results, a maximum nominal DEB diameter of 3.0 mm is permitted. The SELUTION SLR 014 PTCA DEB should then be delivered, positioned in and deployed per instructions per use. The balloon should be inflated for 60 seconds provided that the patient can tolerate this duration. The minimum inflation time is 30 seconds.
"PCI with FDA approved -limus DES"
"For subjects randomized to the control group (DES), the treating physician will choose an FDA cleared DES and follow lesion preparation and stent deployment according to the Instructions per use (IFU) and institutional practices.~The DES should be sized per IFU with respect to the vessel RVD. The use of IVUS or OCT is encouraged to guide optimal stent placement and assess final results. After DES deployment, additional balloon inflations should be performed as needed to obtain \< 30% residual diameter stenosis and resolve proximal or distal edge dissections greater than or equal to NHLBI grade B."
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
RECRUITING
Penn State Health Hershey & Berks, Hershey
RECRUITING
UPMC Pinnacle, Mechanicsburg
RECRUITING
MedStar Washington Hospital Center, Washington D.C.
WITHDRAWN
Johns Hopkins, Baltimore
RECRUITING
HCA Chippenham, Richmond
RECRUITING
NC Heart and Vascular, Raleigh
RECRUITING
Atlanta VA, Atlanta
RECRUITING
Piedmont Heart Institute, Atlanta
RECRUITING
Emory, Atlanta
RECRUITING
Archbold Memorial Hospital, Thomasville
RECRUITING
University of Florida, Jacksonville, Jacksonville
RECRUITING
AdventHealth Orlando, Orlando
WITHDRAWN
HCA Florida JFK, Atlantis
RECRUITING
HCA Largo, Largo
RECRUITING
Mease Countryside Hospital, Clearwater
RECRUITING
HCA Centennial, Nashville
RECRUITING
The Lindner Research Center at Christ, Cincinnati
RECRUITING
Advocate Aurora St. Luke's, Milwaukee
RECRUITING
Minneapolis Heart Institute, Minneapolis
RECRUITING
Minneapolis VA Medical Center, Minneapolis
RECRUITING
Advocate Christ Medical Center, Oak Lawn
RECRUITING
Advocate Good Samaritan Hospital, Downers Grove
RECRUITING
Cardiovascular Research Institute of Kansas, Wichita
RECRUITING
Cardiovascular Institute of the South, Houma
RECRUITING
St. Bernards, Jonesboro
RECRUITING
Baylor Scott and White Plano, Plano
RECRUITING
Baylor Scott and White - Dallas, Dallas
RECRUITING
Medical City of Fort Worth, Fort Worth
RECRUITING
Baylor Scott and White - Temple, Temple
RECRUITING
Hendrick Health, Abilene
RECRUITING
ClinRe, Thornton
RECRUITING
Colorado Heart and Vascular, Golden
RECRUITING
Cedars Sinai, Los Angeles
RECRUITING
Harbor UCLA, Torrance
RECRUITING
HCA Los Robles, Thousand Oaks
RECRUITING
CISD Sharp Chula Vista, Chula Vista
RECRUITING
Beth Israel Deaconess, Boston
RECRUITING
Mass General, Boston
RECRUITING
Brigham & Women's, Boston
RECRUITING
Baystate Medical Center, Springfield
RECRUITING
Englewood Health, Englewood
RECRUITING
Lifespan Rhode Island & Miriam, Providence
Collaborators (2)
NAMSA
OTHER
Cordis Corporation
INDUSTRY
M.A. Med Alliance S.A.
INDUSTRY