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IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)

Primary Purpose

Atherosclerosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Eagle Eye Platinum digital IVUS catheter with optional SyncVision
Resolute Onyx Drug Eluting Stent
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years at screening
  • PCI with stent implantation involving a high risk or complex lesion defined as involving at least one of the following characteristics:
  • Chronic total occlusion
  • In-stent restenosis
  • Severe coronary artery calcification
  • Long lesion (≥ 28 mm in length)
  • Bifurcation lesion (Any Medina class that involves main branch disease with a side branch ≥2.0 mm)
  • Stable angina, unstable angina, or non-ST Elevation myocardial infarction (NSTEMI), undergoing PCI of a single or multivessel coronary artery stenosis
  • PCI performed with either angiography alone, or IVUS guidance used

Exclusion Criteria:

  • Subjects with acute ST elevation myocardial infarction (STEMI), or cardiogenic shock
  • Use of fibrinolytic therapy within 24 hours of PCI
  • Planned revascularization as a staged procedure
  • Stent thrombosis
  • Use of optical coherence tomography (OCT) during the index procedure

Sites / Locations

  • Northwest Medical CenterRecruiting
  • University of California San DeigoRecruiting
  • San Francisco VA Health Care SystemRecruiting
  • San Antonio Regional HospitalRecruiting
  • Medstar Washington Hospital CenterRecruiting
  • Manatee Memorial HospitalRecruiting
  • AdventHealth OrlandoRecruiting
  • Ascension Sacred HeartRecruiting
  • AdventHealth SebringRecruiting
  • Tampa Cardiovascular/St. Joseph's HospitalRecruiting
  • EmoryRecruiting
  • Atlanta VA Medical CenterRecruiting
  • Northeast Georgia Medical CenterRecruiting
  • Riverside Medical CenterRecruiting
  • Carle Foundation HospitalRecruiting
  • MercyOne Iowa Heart Center
  • MedStar Union Memorial HospitalRecruiting
  • MedStar Southern Maryland Hospital CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • Baystate Medical CenterRecruiting
  • Ascension St. JohnRecruiting
  • St. Luke's Hospital of DuluthRecruiting
  • University of MinnesotaRecruiting
  • Virtua Our Lady of Lourdes HospitalRecruiting
  • AtlantiCare Regional Medical CenterRecruiting
  • Northwell Health - South Shore University HospitalRecruiting
  • NYU Langone HospitalRecruiting
  • Northwell Health - North Shore University HospitalRecruiting
  • Northwell Health - Lennox Hill HospitalRecruiting
  • St. FrancisRecruiting
  • SUNY Upstate Medical Center
  • University of North Carolina Rex HospitalRecruiting
  • The Ohio State University Medical CenterRecruiting
  • Lehigh Valley HospitalRecruiting
  • Seton Medical Center AustinRecruiting
  • Texas Tech University Health Sciences CenterRecruiting
  • Carilion ClinicRecruiting
  • St. Vinzenz HospitalRecruiting
  • Herz-und Diabeteszentrum NRWRecruiting
  • DRK Kliniken Berlin Köpenik
  • Helios Amper-Klinikum DachauRecruiting
  • University Medical Center Hamburg-EppendorfRecruiting
  • University of MessinaRecruiting
  • Sahlgrenska University HospitalRecruiting
  • Skane University HospitalRecruiting
  • Danderyd University HospitalRecruiting
  • Leeds General InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IVUS guided PCI

Angiographic-guided PCI

Arm Description

Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS

Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator

Outcomes

Primary Outcome Measures

IVUS core lab measures final PCI Minimum Stent Area
The imaging primary endpoint is the final post-PCI minimum stent area (MSA) assessed by IVUS in each randomized arm, measured at an independent IVUS core laboratory blinded to treatment assignment. The MSA is an appropriate co-primary imaging endpoint as it is the most consistent and strongest parameter to predict clinical outcomes.11-14 In the present study, after 2,000 subjects are enrolled with the procedure completed, the primary endpoint of MSA will be tested to compare the IVUS-guided and angiography-guided arms. If significantly larger MSA in the IVUS-guided arm is demonstrated, the trial will continue enrolling subjects.
Target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related-myocardial infarction (MI), and ischemia-driven target vessel revascularization.
The clinical primary endpoint is target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related- myocardial infarction (MI), and target vessel revascularization.

Secondary Outcome Measures

Full Information

First Posted
December 27, 2019
Last Updated
August 21, 2023
Sponsor
Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04221815
Brief Title
IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact
Acronym
IMPROVE
Official Title
IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent events after PCI. This is accomplished by improving the angiographic result with lesion and vessel assessment to guide stent selection and implantation and intravascular imaging following stent implantation to ensure an adequate treatment endpoint has been achieved. Despite extensive literature supporting the use of IVUS in PCI, utilization remains low in the United States. An increasing number of high-risk or complex lesions are being treated with PCI and we hypothesize that the impact of IVUS in these complex lesions will be of increased importance in reducing clinical adverse events while remaining cost effective.
Detailed Description
This is a prospective, single-blind clinical investigation randomizing subjects to IVUS-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio. The clinical investigation will be conducted at approximately 120 centers in the US, Canada, and Europe. Approximately 2,500-3,100 randomized subjects and up to 3 roll-in subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 2 years. The expected duration of enrollment is approximately 2.5 years. The total duration of the clinical investigation is expected to be approximately 4.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVUS guided PCI
Arm Type
Active Comparator
Arm Description
Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS
Arm Title
Angiographic-guided PCI
Arm Type
Placebo Comparator
Arm Description
Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator
Intervention Type
Device
Intervention Name(s)
Eagle Eye Platinum digital IVUS catheter with optional SyncVision
Intervention Description
IVUS catheter
Intervention Type
Device
Intervention Name(s)
Resolute Onyx Drug Eluting Stent
Intervention Description
Stent
Primary Outcome Measure Information:
Title
IVUS core lab measures final PCI Minimum Stent Area
Description
The imaging primary endpoint is the final post-PCI minimum stent area (MSA) assessed by IVUS in each randomized arm, measured at an independent IVUS core laboratory blinded to treatment assignment. The MSA is an appropriate co-primary imaging endpoint as it is the most consistent and strongest parameter to predict clinical outcomes.11-14 In the present study, after 2,000 subjects are enrolled with the procedure completed, the primary endpoint of MSA will be tested to compare the IVUS-guided and angiography-guided arms. If significantly larger MSA in the IVUS-guided arm is demonstrated, the trial will continue enrolling subjects.
Time Frame
Intra-procedural
Title
Target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related-myocardial infarction (MI), and ischemia-driven target vessel revascularization.
Description
The clinical primary endpoint is target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related- myocardial infarction (MI), and target vessel revascularization.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years at screening PCI with stent implantation involving a high risk or complex lesion defined as involving at least one of the following characteristics: Chronic total occlusion In-stent restenosis Severe coronary artery calcification Long lesion (≥ 28 mm in length) Bifurcation lesion (Any Medina class that involves main branch disease with a side branch ≥2.0 mm) Stable angina, unstable angina, or non-ST Elevation myocardial infarction (NSTEMI), undergoing PCI of a single or multivessel coronary artery stenosis PCI performed with either angiography alone, or IVUS guidance used Exclusion Criteria: Subjects with acute ST elevation myocardial infarction (STEMI), or cardiogenic shock Use of fibrinolytic therapy within 24 hours of PCI Planned revascularization as a staged procedure Stent thrombosis Use of optical coherence tomography (OCT) during the index procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Rowland, MPH
Phone
2028772959
Email
megan.e.rowland@medstar.net
Facility Information:
Facility Name
Northwest Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dexter Deleon
Email
dexterdeleonmd@gmail.com
First Name & Middle Initial & Last Name & Degree
Dexter Deleon
Facility Name
University of California San Deigo
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehtisham Mahmud, MD
Email
emahmud@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ehtisham Mahmud, MD
Facility Name
San Francisco VA Health Care System
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Zimmet
Email
Jeffrey.Zimmet@va.gov
First Name & Middle Initial & Last Name & Degree
Jeffrey Zimmet
Facility Name
San Antonio Regional Hospital
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suraj Rasania, MD
Email
srasania@sarh.org
First Name & Middle Initial & Last Name & Degree
Suraj Rasani, MD
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itsik Ben-Dor
Email
Itsik.BenDor@medstar.net
First Name & Middle Initial & Last Name & Degree
Itsik Ben-Dor, MD
Facility Name
Manatee Memorial Hospital
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santosh Mathews, MD
Email
sjaymathewsmd@gmail.com
First Name & Middle Initial & Last Name & Degree
Santosh Mathews, MD
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Bhatheja, MD
Email
Rohit.Bhatheja.MD@AdventHealth.com
First Name & Middle Initial & Last Name & Degree
Rohit Bhatheja, MD
Facility Name
Ascension Sacred Heart
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Amin, MD
Email
rohit.amin@ascension.org
First Name & Middle Initial & Last Name & Degree
Rohit Amin, MD
Facility Name
AdventHealth Sebring
City
Sebring
State/Province
Florida
ZIP/Postal Code
33870
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas M Shimshak, MD
Email
thomas.shimshak@adventhealth.org
First Name & Middle Initial & Last Name & Degree
Thomas M Shimshak, MD
Facility Name
Tampa Cardiovascular/St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saihari Sadanandan, MD
Email
saihari.sadanandan@gmail.com
First Name & Middle Initial & Last Name & Degree
Saihari Sadanandan, MD
Facility Name
Emory
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wissam A Jaber, MD
Email
wissam.jaber@emory.edu
First Name & Middle Initial & Last Name & Degree
Wissam A Jaber, MD
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gautum Kumar, MD
Email
gautam.kumar@emory.edu
First Name & Middle Initial & Last Name & Degree
Gautum Kumar, MD
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Habib Samady, MD
Email
habib.samady@nghs.com
First Name & Middle Initial & Last Name & Degree
Habib Samady, MD
Facility Name
Riverside Medical Center
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikas K Patel, MD
Email
vpatel@rhc.net
First Name & Middle Initial & Last Name & Degree
Vikas K Patel, MD
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Issam Moussa, MD
Email
moussa.issam@carle.com
First Name & Middle Initial & Last Name & Degree
Issam Moussa, MD
Facility Name
MercyOne Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Terminated
Facility Name
MedStar Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Wang
Email
john.wang@medstar.net
First Name & Middle Initial & Last Name & Degree
John Wang
Facility Name
MedStar Southern Maryland Hospital Center
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Case
Email
brian.c.case@medstar.net
First Name & Middle Initial & Last Name & Degree
Brian Case
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darshan Doshi
Email
Darshan_Doshi@MGH.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Darshan Doshi
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Lotfi
Email
Amir.Lotfi@baystatehealth.org
First Name & Middle Initial & Last Name & Degree
Amir Lotfi
Facility Name
Ascension St. John
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Kaki
Email
amirkaki@hotmail.com
First Name & Middle Initial & Last Name & Degree
Amir Kaki
Facility Name
St. Luke's Hospital of Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Mikesell, DO
Email
Scott.Mikesell@slhduluth.com
First Name & Middle Initial & Last Name & Degree
Scott Mikesell, DO
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ganesh Raveendran, MD
Email
raveen001@umn.edu
First Name & Middle Initial & Last Name & Degree
Ganesh Raveendran, MD
Facility Name
Virtua Our Lady of Lourdes Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luai Tabaza, MD
Email
LTABAZA@virtua.org
First Name & Middle Initial & Last Name & Degree
Luai Tabaza, MD
Facility Name
AtlantiCare Regional Medical Center
City
Pomona
State/Province
New Jersey
ZIP/Postal Code
08240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burak Arkonac, MD
Email
burak.arkonac@atlanticare.org
First Name & Middle Initial & Last Name & Degree
Burak M Arkonac, MD
Facility Name
Northwell Health - South Shore University Hospital
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Gruberg, MD
Email
lgruberg@northwell.edu
First Name & Middle Initial & Last Name & Degree
Luis Gruberg, MD
Facility Name
NYU Langone Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atul Sharma
Email
atul.sharma@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Atul Sharma
Facility Name
Northwell Health - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Gruberg, MD
Email
lgruberg@northwell.edu
First Name & Middle Initial & Last Name & Degree
Luis Gruberg, MD
Facility Name
Northwell Health - Lennox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Gruberg, MD
Email
lgruberg@northwell.edu
First Name & Middle Initial & Last Name & Degree
Luis Gruberg, MD
Facility Name
St. Francis
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Shlofmitz, DO
Email
Evan.Shlofmitz@chsli.org
First Name & Middle Initial & Last Name & Degree
Evan Shlofmitz, DO
Facility Name
SUNY Upstate Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of North Carolina Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willis Wu, MD
Email
Willis.Wu@unchealth.unc.edu
First Name & Middle Initial & Last Name & Degree
Willis Wu, MD
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond D Magorien, MD
Email
Raymond.Magorien@osumc.edu
First Name & Middle Initial & Last Name & Degree
Raymond D Magorien, MD
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shailendra Singh, MD
Email
shailendra.singh@lvhn.org
First Name & Middle Initial & Last Name & Degree
Shailendra Singh, MD
Facility Name
Seton Medical Center Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Gajjar, MD
Email
mark.gajjar@ascension.org
First Name & Middle Initial & Last Name & Degree
Mark Gajjar, MD
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manu Rajachandran, MD
Email
m.rajachandran@ttuhsc.edu
First Name & Middle Initial & Last Name & Degree
Manu Rajachandran, MD
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chalak Berzingi
Email
coberzingi@carilionclinic.org
First Name & Middle Initial & Last Name & Degree
Chalak Berzingi
Facility Name
St. Vinzenz Hospital
City
Cologne
State/Province
North Rhine Westphalia
ZIP/Postal Code
50733
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan-Malte Sinning
Email
jan-malte.sinning@cellitinnen.de
First Name & Middle Initial & Last Name & Degree
Jan-Malte Sinning
Facility Name
Herz-und Diabeteszentrum NRW
City
Bad Oeynhausen
State/Province
NRW
ZIP/Postal Code
32545
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Werner Scholtz
Email
wscholtz@hdz-nrw.de
First Name & Middle Initial & Last Name & Degree
Werner Scholtz
Facility Name
DRK Kliniken Berlin Köpenik
City
Berlin
ZIP/Postal Code
12559
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Helios Amper-Klinikum Dachau
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Witzenbichler, MD
Email
bernhard.witzenbichler@helios-gesundheit.de
First Name & Middle Initial & Last Name & Degree
Bernhard Witzenbichler, MD
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moritz Seiffert, MD
Email
m.seiffert@uke.de
First Name & Middle Initial & Last Name & Degree
Moritz Seiffert, MD
Facility Name
University of Messina
City
Messina
ZIP/Postal Code
98124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Ando
Email
giuseppeando1975@gmail.com
First Name & Middle Initial & Last Name & Degree
Giuseppe Ando
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Völz
Email
sebastian.volz@vgregion.se
First Name & Middle Initial & Last Name & Degree
Sebastian Völz
Facility Name
Skane University Hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Erlinge, MD
Email
david.erlinge@gmail.com
First Name & Middle Initial & Last Name & Degree
David Erlinge, MD
Facility Name
Danderyd University Hospital
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas Persson
Email
jonas.persson@regionstockholm.se
First Name & Middle Initial & Last Name & Degree
Jonas Persson
Facility Name
Leeds General Infirmary
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS13EX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Mozid
Email
abdul.mozid@nhs.net
First Name & Middle Initial & Last Name & Degree
Abdul Mozid

12. IPD Sharing Statement

Citations:
PubMed Identifier
32866927
Citation
Shlofmitz E, Torguson R, Mintz GS, Zhang C, Sharp A, Hodgson JM, Shah B, Kumar G, Singh J, Inderbitzen B, Weintraub WS, Garcia-Garcia HM, Di Mario C, Waksman R. The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale. Am Heart J. 2020 Oct;228:65-71. doi: 10.1016/j.ahj.2020.08.002. Epub 2020 Aug 8.
Results Reference
derived

Learn more about this trial

IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact

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