search
Back to results

Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions

Primary Purpose

Coronary Occlusion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intravascular ultrasonography
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Coronary Occlusion

Eligibility Criteria

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

Inclusion Criteria:

  • patients with coronary angiography showing chronic coronary total

Exclusion Criteria:

  1. Acute coronary syndrome within 3 months.
  2. Patients with previous coronary artery bypass graft (CABG).
  3. Patients with known renal insufficiency (eGFR < 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    intravascular ultrasonography guided

    Angiography guided

    Arm Description

    Outcomes

    Primary Outcome Measures

    outcomes of intravascular ultrasound guided re-canalized CTO during the procedure and composite of cardiac death, myocardial infarction, or target vessel revascularization
    the study will assess the composite of cardiac death, myocardial infarction, or target vessel revascularization, rehospitalization, coronary artery bypass surgery and stroke within both groups

    Secondary Outcome Measures

    Full Information

    First Posted
    May 17, 2017
    Last Updated
    May 17, 2017
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03159650
    Brief Title
    Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions
    Official Title
    Randomized Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2017 (Anticipated)
    Primary Completion Date
    June 1, 2019 (Anticipated)
    Study Completion Date
    October 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Chronic total occlusion is defined as thrombolysis in myocardial infarction (TIMI) flow grade 0 with an estimated duration of at least 3 months. The interest in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has increased, but with failure rate up to 20%, leading to important developments in dedicated equipment and techniques. In the 2014 European Guidelines on Myocardial Revascularization, intravascular ultrasound was recommended to guide stent implantation in selected patients, and this recommendation was a class IIa/level of evidence B. In CTO PCI, certain angiographic features such as blunt proximal CTO cap, tortuosity, heavy calcification, and lack of visibility of path in the distal vessel increase procedural difficulty

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intravascular ultrasonography guided
    Arm Type
    Experimental
    Arm Title
    Angiography guided
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    intravascular ultrasonography
    Intervention Description
    intravascular ultrasonography will be used during the study for the resolving proximal cap ambiguity of chronic total occlusion, facilitating re-entry into the true lumen after subintimal crossing and confirming distal true lumen guidewire position
    Primary Outcome Measure Information:
    Title
    outcomes of intravascular ultrasound guided re-canalized CTO during the procedure and composite of cardiac death, myocardial infarction, or target vessel revascularization
    Description
    the study will assess the composite of cardiac death, myocardial infarction, or target vessel revascularization, rehospitalization, coronary artery bypass surgery and stroke within both groups
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with coronary angiography showing chronic coronary total Exclusion Criteria: Acute coronary syndrome within 3 months. Patients with previous coronary artery bypass graft (CABG). Patients with known renal insufficiency (eGFR < 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hosam Hasan, professor
    Phone
    +20882361015
    Email
    hosam_hasan@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed karim, assistant professor
    Phone
    +201119340685
    Email
    m_koriem2004@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25524605
    Citation
    Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Uva MS, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A; Grupa Robocza Europejskiego Towarzystwa Kardiologicznego (ESC); Europejskie Stowarzyszenie Chirurgii Serca i Klatki Piersiowej (EACTS) do spraw rewaskularyzacji miesnia sercowego; European Association for Percutaneous Cardiovascular Interventions (EAPCI). [2014 ESC/EACTS Guidelines on myocardial revascularization]. Kardiol Pol. 2014;72(12):1253-379. doi: 10.5603/KP.2014.0224. No abstract available. Polish.
    Results Reference
    background
    PubMed Identifier
    19942305
    Citation
    Park Y, Park HS, Jang GL, Lee DY, Lee H, Lee JH, Kang HJ, Yang DH, Cho Y, Chae SC, Jun JE, Park WH. Intravascular ultrasound guided recanalization of stumpless chronic total occlusion. Int J Cardiol. 2011 Apr 14;148(2):174-8. doi: 10.1016/j.ijcard.2009.10.052. Epub 2009 Nov 26.
    Results Reference
    background
    PubMed Identifier
    16230504
    Citation
    Stone GW, Reifart NJ, Moussa I, Hoye A, Cox DA, Colombo A, Baim DS, Teirstein PS, Strauss BH, Selmon M, Mintz GS, Katoh O, Mitsudo K, Suzuki T, Tamai H, Grube E, Cannon LA, Kandzari DE, Reisman M, Schwartz RS, Bailey S, Dangas G, Mehran R, Abizaid A, Moses JW, Leon MB, Serruys PW. Percutaneous recanalization of chronically occluded coronary arteries: a consensus document: part II. Circulation. 2005 Oct 18;112(16):2530-7. doi: 10.1161/CIRCULATIONAHA.105.583716. No abstract available.
    Results Reference
    background

    Learn more about this trial

    Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions

    We'll reach out to this number within 24 hrs