Clinical Trial Details

NCT ID: NCT02605447
Date Last Changed: July 26, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating 3 months of dual antiplatelet therapy (DAPT) and SYNERGY Stent System for the treatment of Coronary Artery Disease

Research Study Title

A Prospective, Multicenter, Single-arm Study Designed to Assess the Safety of 3-month Dual Antiplatelet Therapy (DAPT) in Subjects at High Risk for Bleeding Undergoing Percutaneous Coronary Intervention (PCI) With the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

Purpose

The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.

To Learn more

Recruitment Details

Phase
4
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Boston Scientific Corporation
Duration
39 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  1. Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:

  2. ≥ 75 years of age and, in the opinion of the investigator, the risk of major bleeding associated with > 3 months of DAPT outweighs the benefit,

  3. history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,

  4. history of stroke (ischemic or hemorrhagic),

  5. renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),

  6. platelet count ≤100,000/μL

  7. Subject must be at least 18 years of age

  8. Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days

  9. Subject must be able to take study required antiplatelet therapy (as required per protocol)

  10. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol

  11. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed

  12. For subjects less than 20 years of age enrolled at a Japanese site, the subject/ the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed

Exclusion Criteria:

  1. Subject who is taking (or is planning to take) chronic or lifelong anticoagulation within 15 months following index procedure.

  2. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)

  3. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition

  4. Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure

  5. Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).

  6. Subject has a known allergy to contrast (that cannot be adequately pre-medicated), the SYNERGY stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)

  7. Subject with implantation of a drug-eluting stent within 9 months prior to index procedure

  8. Subject previously treated at any time with intravascular brachytherapy

  9. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding

  10. Subject is participating in an investigational drug or device clinical trial that has not reached its primary endpoint (Note: registry, observational, data collection studies are not exclusionary)

  11. Subject intends to participate in an investigational drug or device clinical trial within 15 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)

  12. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use

  13. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure

  14. Subject is a woman who is pregnant or nursing

  15. Subject with a current medical condition with a life expectancy of less than 15 months

  16. Target lesion(s) is located in the left main

  17. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate

  18. Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)

  19. Planned treatment of more than 3 lesion

  20. Planned treatment of lesions in more than 2 major epicardial vessels

  21. Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)

  22. Target lesion(s) is restenotic from a previous stent implantation

  23. Target lesion(s) is located within a saphenous vein graft or an arterial graft

  24. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing

  25. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Site Locations (106)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85006 Banner Good Samaritan Regional Medical Center
Akil Loli, MD
602-952-0002
loliakil1@gmail.com
United States Arizona Phoenix 85013 St. Joseph's Hospital & Medical Center
Hursh Naik, MD
623-433-0202
hursh.naik@imsaz.com
United States Arkansas Little Rock 72205 Baptist Health Medical Center (Little Rock)
Scott Davis, MD
501-227-7596
sdavis@arcard.org
United States Arkansas Little Rock 72211 Arkansas Heart Hospital
David Mego, MD
501-614-3621
david.mego@arheart.com
United States California Bakersfield 93301 Bakersfield Memorial Hospital
Tommy Lee, MD
661-321-3161
tclhrtdoc@yahoo.com
United States California Los Angeles 90033 USC Medical Center
Ray Matthews, MD
323-442-6135
raymatth@usc.edu
United States California Los Angeles 90048 Cedars - Sinai Medical Center
Suhail Dohad, MD
310-248-8245
suhail.dohad@cshs.org
United States California Riverside 92506 HCA Riverside Community Hospital
Syed Bokhari, MD
951-682-6900
heartdr@hotmail.com
United States California Sacramento 95816 Sutter Medical Center, Sacramento
Pei-Hsiu Huang, MD
916-733-1788
huangp@sutterhealth.org
United States California Sacramento 95817 University of California, Davis Medical Center
Reginald Low, MD
916-703-7073
ptcra@aol.com
United States California San Francisco 94115 Kaiser Foundation Hospital - San Francisco
Robert Lundstrom, MD
415-833-2616
robert.lundstrom@kp.org
United States California Torrance 90502 Harbor UCLA Medical Center
Quang Bui, MD
310-222-2695
qbui@labiomed.org
United States California Walnut Creek 94598 John Muir Medical Center
Gary Gershony, MD
925-674-2580
ggershony@comcast.net
United States Colorado Littleton 80120 South Denver Cardiology Associates, PC
Lee MacDonald, MD
303-744-1065
leeamacdonald@hotmail.com
United States Connecticut New Haven 06510 Yale-New Haven Hospital
Robert Attaran, MD
203-785-4129
robert.attaran@yale.edu
United States District of Columbia Washington, D.C. 20010 Washington Hospital Center
Ron Waksman, MD
202-877-5975
ron.waksman@medstar.net
United States Florida Atlantis 33462 JFK Medical Center
Mark Rothenberg, MD
561-548-5538
mdrothmd@yahoo.com
United States Florida Clearwater 33756 Morton Plant Mease Healthcare System
Bernardo Stein, MD
727-445-7911
boydj@cccheart.com
United States Florida Gainesville 32605 North Florida Regional Medical Center
Daniel VanRoy, MD
352-375-1212
danvanroy@yahoo.com
United States Florida Hollywood 33021 Memorial Regional Hospital
Jonathan Roberts, MD
954-265-7900
jonathanroberts@mhs.net
United States Florida Ocala 34471 Mediquest Research at Munroe Regional Medical Center
Robert Feldman, MD
352-351-7337
bob@mediquestresearch.com
United States Florida Orlando 32803 Florida Hospital
Rohit Bhatheja, MD
407-894-4474
rohit.bhatheja.md@flhosp.org
United States Florida Sebring 33870 Florida Hospital Heartland Medical Center
Thomas Shimshak, MD
863-471-3926
thomas.shimshak@ahss.org
United States Florida Tallahassee 32308 Tallahassee Memorial Hospital
Wayne Batchelor, MD
850-431-5024
wabat@southern-med.com
United States Georgia Augusta 30901 University Hospital
Patrick Hall, MD
706-724-3473
paxhall@earthlink.net
United States Georgia Macon 31201 Medical Center of Central Georgia
Mark Dorogy, MD
478-741-1208
mdorogy@bellsouth.net
United States Georgia Marietta 30060 Wellstar Kennestone Hospital
Amar Patel, MD
770-424-6893
amar.patel@wellstar.org
United States Idaho Coeur d'Alene 83814 Kootenai Medical Center
Ronald Jenkins, MD
208-625-5250
rjenkins@kh.org
United States Illinois Chicago 60611 Northwestern Memorial Hospital
Mark Ricciardi, MD
312-926-2826
mark.ricciardi@northwestern.edu
United States Illinois Naperville 60566 Edward Hospital
Mark Goodwin, MD
630-527-2730
mark.goodwin@advocatehealth.com
United States Illinois Springfield 62701 St. John's Hospital
Nilesh Goswami, MD
217-788-0706
ngoswami@prairieheart.com
United States Illinois Urbana 61801 Carle Foundation Hospital
Naveed Adoni, MD
217-904-7276
naveed.adoni@carle.com
United States Indiana Beech Grove 46237 Franciscan St. Francis Hospital
Saeed Shaikh, MD
317-893-1917
srs.ihp@sbcglobal.net
United States Indiana Fort Wayne 46804 Northern Indiana Research Alliance - Lutheran Hospital
Mark Meier, MD
260-434-6325
meierma10@gmail.com
United States Indiana Indianapolis 46250 Community Heart and Vascular Hospital
Sandeep Dube, MD
317-621-8500
sdube@ecommunity.com
United States Iowa Des Moines 50314 Mercy Hospital Medical Center
Magdi Ghali, MD
515-633-3600
mghali@iowaheart.com
United States Kentucky Louisville 40202 Jewish Hospital and St. Mary's Healthcare
Naresh Solankhi, MD
502-540-3409
solankhi@twc.com
United States Louisiana Shreveport 71103 Cardiovascular Research, LLC
James Smith, MD
318-795-4638
jfs@acsdoctors.com
United States Maine Portland 04102 Maine Medical Center
Samip Vasaiwala, MD
207-774-2642
samip.vasaiwala@mhcardio.com
United States Maryland Baltimore 21218 Union Memorial Hospital
John Wang, MD
410-554-2332
john.wang@medstar.net
United States Massachusetts Boston 02111 Tufts Medical Center
Carey Kimmelstiel, MD
617-636-5914
CKimmelstiel@tuftsmedicalcenter.org
United States Massachusetts Boston 02115 Brigham and Women's Hospital
Laura Mauri, MD
617-732-8936
lmauri1@partners.org
United States Massachusetts Boston 02215 Beth Israel Deaconess Medical Center
Duane Pinto, MD
617-667-8800
dpinto@bidmc.harvard.edu
United States Michigan Detroit 48202 Henry Ford Hospital
Khaldoon Alaswad, MD
313-916-9898
kalaswa1@hfhs.org
United States Minnesota Duluth 55805 St. Mary's Duluth Clinic Regional Heart Center
Wilson Ginete, MD
218-786-8364
wilson.ginete@essentiahealth.org
United States Minnesota Minneapolis 55407 Abbott Northwestern Hospital
Ivan Chavez, MD
612-863-3900
ivan.chavez@allina.com
United States Minnesota Saint Paul 55102 HealthEast St. Joseph's Hospital
Mudassar Ahmed, MD
218-786-8364
mudassar.ahmed@essentiahealth.org
United States Missouri Kansas City 64111 St. Luke's Hospital of Kansas City
Steven Laster, MD
816-932-6275
slaster@cc-pc.com
United States Missouri Saint Louis 63110 Washington University School of Medicine
Jasvindar Singh, MD
314-747-4421
jsingh@wustl.edu
United States Missouri Springfield 65802 Cox Medical Centers
Steven Rowe, MD
471-269-6681
Steven.Rowe@coxhealth.com
United States New Hampshire Lebanon 03756-1000 Dartmouth Hitchcock Medical Center
James DeVries, MD
603-650-0808
james.t.devries@hitchcock.org
United States New Jersey Browns Mills 08015 Deborah Heart and Lung Center
Richard Kovach, MD
609-893-1200
kovachr@deborah.org
United States New Jersey Morristown 07960 Morristown Memorial Hospital
Jordan Safirstein, MD
973-971-5000
jsaf237@yahoo.com
United States New Mexico Albuquerque 87106 Presbyterian Hospital
Kayvan Ellini, MD
505-563-2500
kellini@phs.org
United States New York Manhasset 11030 North Shore University Hospital
Loukas Boutis, MD
516-562-4100
lboutis@northwell.edu
United States New York New York 10016 New York University Medical Center
Michael Attubato, MD
212-263-5656
michael.attubato@nyumc.org
United States New York New York 10032 Columbia University Medical Center/ NewYork Presbyterian Hospital
Manish Parikh, MD
212-342-3488
map2224@cumc.columbia.edu
United States New York Syracuse 13202 St. Joseph's Hospital Health Center
Ronald Caputo, MD
315-448-6215
caputo331@msn.com
United States North Carolina Charlotte 28203 Carolinas Medical Center
Michael Rinaldi, MD
704-355-2000
michael.rinaldi@carolinashealthcare.org
United States North Carolina Raleigh 27610 Wake Medical Center
Islam Othman, MD
919-350-8317
iothman@wakemed.org
United States Ohio Cincinnati 45219 Lindner Center for Research and Education at Christ Hospital
Dean Kereiakes, MD
513-585-2000
lindnermd@thechristhospital.com
United States Ohio Cincinnati 45220 Good Samaritan Hospital
Dogan Temizer, MD
513-861-1260
dogan_temizer@trihealth.com
United States Ohio Columbus 03210 Ohio State University Medical Center
Cindy Baker, MD
614-293-4967
cindy.baker@osumc.edu
United States Ohio Columbus 43214 OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Steven Yakubov, MD
614-566-5149
steven.yakubov@ohiohealth.com
United States Ohio Toledo 43608 Mercy St. Vincent Medical Center
Ameer Kabour, MD
419-251-4919
akabour@toledocardiology.com
United States Oklahoma Oklahoma City 73112 Integris Baptist Medical Center
George Chrysant, MD
405-947-3341
gsc5@yahoo.com
United States Oklahoma Oklahoma City 73120 Oklahoma Heart Hospital
Naeem Tahirkheli, MD
405-628-6865
ntahirkheli@okheart.com
United States Oregon Portland 97225 Providence St. Vincent Medical Center
Ethan Korngold, MD
505-216-0900
ethan.korngold@providence.org
United States Pennsylvania Danville 17822 Geisinger Medical Center
James Blankenship, MD
570-271-6736
jblankenship@geisinger.edu
United States Pennsylvania Pittsburgh 15213 University of Pittsburgh Medical Center
Saul Silver, MD
412-621-1500
silvers@upmc.edu
United States Pennsylvania Wynnewood 19096 Lankenau Hospital
Timothy Shapiro, MD
610-526-4240
shapirot@mlhs.org
United States South Carolina Columbia 29204 Sisters of Charity Providence Hospital
Michael Foster, MD
803-255-2927
mfoster@scheart.com
United States South Carolina Greenville 29605 University Medical Center-Greenville Memorial Hospital
Joseph Henderson, MD
864-455-6900
jhenderson@ghs.org
United States South Carolina Myrtle Beach 29572 Grand Strand Regional Medical Center
Randy Goodroe, MD
843-449-3381
Randy.goodroe@gmail.com
United States Tennessee Jackson 38301 Jackson-Madison County General Hospital
Henry Lui, MD
731-423-8200
kinsunlui@gmail.com
United States Tennessee Nashville 37203 Centennial Medical Center
Brian Jefferson, MD
615-515-1900
brian.jefferson@hcahealthcare.com
United States Texas Dallas 75226 Baylor Heart & Vascular Hospital
Robert Stoler, MD
214-820-9903
rcstoler@gmail.com
United States Texas Houston 77030 St. Luke's Episcopal Hospital
Ali Mortazavi, MD
713-442-0965
ali.mortazavi@kelsey-seybold.com
United States Texas Houston 77074 Memorial Hermann Southwest
Pranav Loyalka, MD
713-486-6715
pranavloyalka@gmail.com
United States Texas Plano 75093 The Heart Hospital Baylor Plano
Molly Szerlip, MD
mszerlip@me.com
United States Texas Round Rock 78681 St. David's Round Rock Medical Center
Craig Siegel, MD
512-341-0889
csiegel@austinheart.com
United States Vermont Burlington 05401 The University of Vermont Medical Center
Harold Dauerman, MD
802-847-4746
harold.dauerman@uvmhealth.org
United States Virginia Norfolk 23507 Sentara Norfolk General Hospital
Neville Mistry, MD
757-388-5480
nfmistry@sentara.com
United States Virginia Winchester 26015 Winchester Medical Center
Jason Call, MD
540-536-8978
jasontcall@yahoo.com
United States Washington Seattle 98122 Swedish Medical Center
Jeffrey Westcott, MD
206-215-4545
jeffrey.westcott@swedish.org
United States Washington Seattle 98195 University of Washington Medical Center
Creighton Don, MD
206-598-8714
cwdon@uw.edu
United States West Virginia Charleston 25304 Charleston Area Medical Center
Elie Gharib, MD
304-388-9945
eliegharib@yahoo.com
United States Wisconsin Milwaukee 53215 Aurora St. Luke's Medical Center
Suhail Allaqaband, MD
414-649-3491
Suhail.Allaqaband@aurora.org
United States Wisconsin Wausau 54401 Aspirus Heart and Vascular Institute - Research and Education
Timothy Grady, MD
715-847-2273
timothy.grady@aspirus.org
Brazil Sao Paulo 05403-000 Instituto do Coração (InCor)
Pedro Lemos, MD
+55 11 2661-5961
pedro.lemos@incor.usp.br
Brazil São Paulo 04012-909 Instituto de Cardiologia Dante Pazzanese
Alexandre Antonio Cunha Abizaid, MD
+55 1150854141
aabizaid@uol.com.br
Germany Bad Krozingen 79189 Herzzentrum Bad Krozingen
Franz-Josef Neumann, Prof, MD
+49 7633 402-2001
franz-josef.neumann@universitaets-herzzentrum.de
Germany Bad Segeberg 23795 Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Ralph Ernst Toelg, MD
+49 4551 802 4801
ralph.toelg@segebergerkliniken.de
Germany Heidelberg 69120 Universitaetsklinikum Heidelberg
Raffi Bekeredjian, MD
+49 6221-56-38797
raffi_bekeredjian@med.uni-heidelberg.de
Germany Jena 07740 Uni Jena
Christian Schultz, MD
+4936419324131
christian.schulze@med.uni-jena.de
Japan Fukuoka Fukuoka-shi 814-0001 Fukuoka Sanno Hospital
Hiroyoshi Yokoi, MD
+81-92-832-1100
hiroyokoi@circus.ocn.ne.jp
Japan Kanagawa Isehara-shi 259-1193 Tokai University Hospital
Yuji Ikari, MD
+81463934145
ikari@is.icc.u-tokai.ac.jp
Japan Kanagawa Yokohama-shi 230-8765 Saiseikai Yokohama-City Eastern Hospital
Yoshiaki Ito, MD
+81118315151
y_ito@tobu.saiseikai.or.jp
Japan Tokyo Itabashi-ku 173-8606 Teikyo University Hospital
Ken Kozuma, MD
+81339641211
pxe00364@nifty.com
Japan Tokyo Meguro-ku 153-8515 Toho University Ohashi Medical Center
Masato Nakamura, MD
+81334681251
masato@oha.toho-u.ac.jp
Japan Osaka Osaka Saiseikai Nakatsu Hospital
Junya Shite, MD
+81663720333
shitej1@yahoo.co.jp
Latvia Riga LV-1002 P. Stradins University Hospital
Andrejs Erglis, MD
+371 67069379
a.a.erglis@stradini.lv
Sweden Falun 79182 Falu Lasarett
Iwar Sjoegren, MD
+462) 349-0979
iwar.sjogren@ltdalarna.se
Sweden Karlstad 65185 Karlstadt Central Hospital
Hans Olsson, MD
+0046-(0)54-191401
Sweden Malmo SE-214 28 Skane University Hospital
Matthias Goetberg, MD
+46 46 17 76 77
matthias.gotberg@med.lu.se
Switzerland Fribourg 1708 Hospital Cantonal Fribourg
Stephane Cook, MD
+41264268140
stephanecook@me.com

Contact

Peter Maurer
508-683-6678
E-mail:

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