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Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire (Gladius First) (Gladius First)

Primary Purpose

Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
CTO PCI with the first-choice Gladius guidewire
CTO PCI without the first-choice Gladius guidewire
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  • delivery of an informed consent and compliance with study protocol
  • CTO of a major coronary artery with at least intermediate difficulty score (J-CTO ≥1) as assessed by invasive angiography
  • referral to clinically indicated CTO PCI with intended primary antegrade wiring strategy

Exclusion Criteria:

  • in-stent CTO
  • unstable angina and/or myocardial infarction
  • prior myocardial infarction within 4 weeks before study enrolment
  • CTO of a major coronary artery with an easy difficulty score (J-CTO 0) as assessed by invasive coronary angiography
  • lack of valid antegrade wire escalation strategy as assessed by 2 independent CTO PCI operators
  • chronic kidney disease (defined as eGFR ≤30 ml/min/m2)
  • contraindication to antiplatelet therapy and/or heparin
  • severe inflammatory disease
  • positive pregnancy test or breast-feeding

Sites / Locations

  • National Institute of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

CTO PCI using antegrade wiring strategy starting with the Gladius guidewire

CTO PCI using standard antegrade wire escalation strategy

Arm Description

Study subjects will undergo CTO PCI with primary antegrade wiring strategy starting with the Gladius guidewire. In case of failed CTO crossing with the Gladius wire, the decision on continuing antegrade wire escalation with a different wire or switching to a different CTO PCI strategy will be left to the discretion of the operator.

Control subjects will undergo CTO PCI using standard antegrade wiring strategy starting with the lower/intermediate penetration force guidewires and, if necessary, escalating up to high gram-force guidewires, but without the use of first-choice Gladius guidewire.

Outcomes

Primary Outcome Measures

time-efficiency of antegrade wiring strategy
time-efficiency of antegrade wiring strategy defined as the time from advancement of the first wire into the proximal cap to either the time of successful antegrade wiring through the lesion or the time of cessation of antegrade wiring and changing CTO PCI strategy according to the hybrid algorithm

Secondary Outcome Measures

time-efficiency of successful antegrade wiring strategy
time-efficiency of successful antegrade wiring strategy defined as the time from advancement of the first wire into the proximal cap to the time of successful antegrade wiring through the lesion
time-efficiency of successful antegrade approach
time-efficiency of successful antegrade approach defined as the time from advancement of the first wire into the proximal cap to either the time of successful antegrade wiring through the lesion or successful antegrade dissection and re-entry strategy
time-efficiency of antegrade approach
time-efficiency of antegrade approach defined as the time from advancement of the first wire into the proximal cap to either the time of successful antegrade wiring or antegrade dissection and re-entry strategy or the time of failed antegrade approach and changing CTO PCI strategy according to the hybrid algorithm
time-efficiency of successful CTO recanalization using any technique
time-efficiency defined as the time from advancement of the first wire into the proximal cap to the time of successful CTO recanalization using any technique (including antegrade and retrograde strategies)
total procedural time
total procedural time defined as the time from getting arterial access to the time of removal of the arterial sheaths
successful guidewire crossing through CTO using antegrade wiring strategy
successful guidewire crossing through CTO using antegrade wiring strategy
successful guidewire crossing through CTO with restoration of flow using antegrade wiring strategy
successful guidewire crossing through CTO with restoration of flow (<50% residual stenosis and TIMI flow grade 3) using antegrade wiring strategy
successful guidewire crossing through CTO using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
successful guidewire crossing through CTO using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
successful guidewire crossing through CTO with restoration of flow using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
successful guidewire crossing through CTO with restoration of flow (<50% residual stenosis and TIMI flow grade 3) using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
final procedural success defined as successful guidewire crossing through CTO with restoration of flow
final procedural success defined as successful guidewire crossing through CTO with restoration of flow (<50% residual stenosis and TIMI flow grade 3)
contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy
contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy
total contrast volume
total contrast volume
radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy
radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy
total radiation dose
total radiation dose
incidence of periprocedural complications
incidence of periprocedural complications defined as: coronary perforation, tamponade, life-threatening arrhythmia requiring treatment, transient ischemic attack, stroke, myocardial infarction, urgent cardiac surgery, death

Full Information

First Posted
December 18, 2020
Last Updated
December 30, 2020
Sponsor
National Institute of Cardiology, Warsaw, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT04691778
Brief Title
Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire (Gladius First)
Acronym
Gladius First
Official Title
Coronary Chronic Total Occlusion Percutaneous Coronary Intervention Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire: a Randomized Clinical Study (Gladius First Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland

4. Oversight

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

5. Study Description

Brief Summary
The Gladius First trial is designed as a single-centre, open, prospective, randomized clinical trial aimed to assess the efficiency and safety of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using the antegrade wiring strategy with a first-choice intermediate Gladius guidewire. To this end, consecutive patients referred to CTO PCI with intended primary antegrade wire escalation strategy, will be randomized in a 1:1 fashion to antegrade wiring starting with the Gladius guidewire or antegrade wiring using the standard guidewire escalation strategy.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CTO PCI using antegrade wiring strategy starting with the Gladius guidewire
Arm Type
Active Comparator
Arm Description
Study subjects will undergo CTO PCI with primary antegrade wiring strategy starting with the Gladius guidewire. In case of failed CTO crossing with the Gladius wire, the decision on continuing antegrade wire escalation with a different wire or switching to a different CTO PCI strategy will be left to the discretion of the operator.
Arm Title
CTO PCI using standard antegrade wire escalation strategy
Arm Type
Other
Arm Description
Control subjects will undergo CTO PCI using standard antegrade wiring strategy starting with the lower/intermediate penetration force guidewires and, if necessary, escalating up to high gram-force guidewires, but without the use of first-choice Gladius guidewire.
Intervention Type
Procedure
Intervention Name(s)
CTO PCI with the first-choice Gladius guidewire
Intervention Description
CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire
Intervention Type
Procedure
Intervention Name(s)
CTO PCI without the first-choice Gladius guidewire
Intervention Description
CTO PCI using standard antegrade wire escalation strategy
Primary Outcome Measure Information:
Title
time-efficiency of antegrade wiring strategy
Description
time-efficiency of antegrade wiring strategy defined as the time from advancement of the first wire into the proximal cap to either the time of successful antegrade wiring through the lesion or the time of cessation of antegrade wiring and changing CTO PCI strategy according to the hybrid algorithm
Time Frame
during procedure (intraprocedural)
Secondary Outcome Measure Information:
Title
time-efficiency of successful antegrade wiring strategy
Description
time-efficiency of successful antegrade wiring strategy defined as the time from advancement of the first wire into the proximal cap to the time of successful antegrade wiring through the lesion
Time Frame
during procedure (intraprocedural)
Title
time-efficiency of successful antegrade approach
Description
time-efficiency of successful antegrade approach defined as the time from advancement of the first wire into the proximal cap to either the time of successful antegrade wiring through the lesion or successful antegrade dissection and re-entry strategy
Time Frame
during procedure (intraprocedural)
Title
time-efficiency of antegrade approach
Description
time-efficiency of antegrade approach defined as the time from advancement of the first wire into the proximal cap to either the time of successful antegrade wiring or antegrade dissection and re-entry strategy or the time of failed antegrade approach and changing CTO PCI strategy according to the hybrid algorithm
Time Frame
during procedure (intraprocedural)
Title
time-efficiency of successful CTO recanalization using any technique
Description
time-efficiency defined as the time from advancement of the first wire into the proximal cap to the time of successful CTO recanalization using any technique (including antegrade and retrograde strategies)
Time Frame
during procedure (intraprocedural)
Title
total procedural time
Description
total procedural time defined as the time from getting arterial access to the time of removal of the arterial sheaths
Time Frame
during procedure (intraprocedural)
Title
successful guidewire crossing through CTO using antegrade wiring strategy
Description
successful guidewire crossing through CTO using antegrade wiring strategy
Time Frame
during procedure (intraprocedural)
Title
successful guidewire crossing through CTO with restoration of flow using antegrade wiring strategy
Description
successful guidewire crossing through CTO with restoration of flow (<50% residual stenosis and TIMI flow grade 3) using antegrade wiring strategy
Time Frame
during procedure (intraprocedural)
Title
successful guidewire crossing through CTO using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
Description
successful guidewire crossing through CTO using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
Time Frame
during procedure (intraprocedural)
Title
successful guidewire crossing through CTO with restoration of flow using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
Description
successful guidewire crossing through CTO with restoration of flow (<50% residual stenosis and TIMI flow grade 3) using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
Time Frame
during procedure (intraprocedural)
Title
final procedural success defined as successful guidewire crossing through CTO with restoration of flow
Description
final procedural success defined as successful guidewire crossing through CTO with restoration of flow (<50% residual stenosis and TIMI flow grade 3)
Time Frame
during procedure (intraprocedural)
Title
contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy
Description
contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy
Time Frame
during procedure (intraprocedural)
Title
total contrast volume
Description
total contrast volume
Time Frame
during procedure (intraprocedural)
Title
radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy
Description
radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy
Time Frame
during procedure (intraprocedural)
Title
total radiation dose
Description
total radiation dose
Time Frame
during procedure (intraprocedural)
Title
incidence of periprocedural complications
Description
incidence of periprocedural complications defined as: coronary perforation, tamponade, life-threatening arrhythmia requiring treatment, transient ischemic attack, stroke, myocardial infarction, urgent cardiac surgery, death
Time Frame
during hospitalization (assessed up to 30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: delivery of an informed consent and compliance with study protocol CTO of a major coronary artery with at least intermediate difficulty score (J-CTO ≥1) as assessed by invasive angiography referral to clinically indicated CTO PCI with intended primary antegrade wiring strategy Exclusion Criteria: in-stent CTO unstable angina and/or myocardial infarction prior myocardial infarction within 4 weeks before study enrolment CTO of a major coronary artery with an easy difficulty score (J-CTO 0) as assessed by invasive coronary angiography lack of valid antegrade wire escalation strategy as assessed by 2 independent CTO PCI operators chronic kidney disease (defined as eGFR ≤30 ml/min/m2) contraindication to antiplatelet therapy and/or heparin severe inflammatory disease positive pregnancy test or breast-feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maksymilian P. Opolski, MD, PhD
Phone
+48501444303
Email
mopolski@ikard.pl
Facility Information:
Facility Name
National Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maksymilian P. Opolski, MD, PhD
Phone
+48501444303
Email
mopolski@ikard.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire (Gladius First)

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