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Femoral or Radial Approach in Coronary Chronic Total Occlusion

Primary Purpose

Chronic Coronary Occlusion

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
radial access site
femoral access site
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Coronary Occlusion focused on measuring Femoral approach, Radial approach, Chronic total occlusion

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient with coronary total occlusion >3 months and indication for intervention

Exclusion Criteria:

  • Acute coronary syndrome within 3 months

Sites / Locations

  • Acibadem University
  • Haseki Cradiology Institute
  • Memorial Hospital
  • Erciyes University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transradial approach

Transfemoral approach

Arm Description

target vessel revascularization via radial access site is labeled as transradial approach

target vessel revascularization via femoral access site is labeled as transfemoral approach

Outcomes

Primary Outcome Measures

Procedural success
Technical success without any in-hospital event

Secondary Outcome Measures

Major access site complications
Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm

Full Information

First Posted
August 27, 2017
Last Updated
September 10, 2021
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT03265769
Brief Title
Femoral or Radial Approach in Coronary Chronic Total Occlusion
Official Title
Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial (FORT CTO TRIAL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acibadem University

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
Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly performed using bilateral transfemoral access and 8 French guiding catheters. However, transfemoral approach (TFA) is associated with higher risk of vascular access complications.5 It has been reported that using transradial approach (TRA) reduces vascular complications and may be associated with a better clinical outcome. Transradial access is also used in complex PCI interventions.There is a growing body of evidence regarding the use of this approach also in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO consisted of single center and single operator experience. Besides, none of them is randomized. To fill in the gap, we sought to examine the technique and outcomes of transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.
Detailed Description
All consecutive patients referred for CTO PCI between August 2017 and July 2021 at Acibadem University Kocaeli Acibadem Hospital, Kocaeli; Erciyes University Medical Faculty, Kayseri; Istanbul University Cerrahpasa Medical Faculty, Haseki Cardiology Institute; Istanbul; Memorial Bahcelievler Hospital, Istanbul were screened for enrollment in the study. The exclusion criteria included: (a) any acute coronary syndrome within 3 months; (b) severe heart failure issues; (c)severe renal failure (d) failure to provide written informed consent.The radial access group consisted of patients with single or bi-radial approach. Any femoral artery puncture was considered a femoral case. For example, a crossover from any radial to femoral access was considered a femoral case. Procedures were performed by 4 interventional cardiologists, who are dedicated radial operators, at 4 different centers. The protocol was approved by the institutional review board and all patients provided written informed consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Coronary Occlusion
Keywords
Femoral approach, Radial approach, Chronic total occlusion

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Transradial approach
Arm Type
Active Comparator
Arm Description
target vessel revascularization via radial access site is labeled as transradial approach
Arm Title
Transfemoral approach
Arm Type
Active Comparator
Arm Description
target vessel revascularization via femoral access site is labeled as transfemoral approach
Intervention Type
Other
Intervention Name(s)
radial access site
Intervention Description
radial route
Intervention Type
Other
Intervention Name(s)
femoral access site
Intervention Description
femoral route
Primary Outcome Measure Information:
Title
Procedural success
Description
Technical success without any in-hospital event
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Major access site complications
Description
Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient with coronary total occlusion >3 months and indication for intervention Exclusion Criteria: Acute coronary syndrome within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevket Gorgulu, MD
Organizational Affiliation
Acibadem University
Official's Role
Study Chair
Facility Information:
Facility Name
Acibadem University
City
İstanbul
Country
Turkey
Facility Name
Haseki Cradiology Institute
City
Istanbul
Country
Turkey
Facility Name
Memorial Hospital
City
Istanbul
Country
Turkey
Facility Name
Erciyes University
City
Kayseri
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
35450683
Citation
Gorgulu S, Kalay N, Norgaz T, Kocas C, Goktekin O, Brilakis ES. Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial. JACC Cardiovasc Interv. 2022 Apr 25;15(8):823-830. doi: 10.1016/j.jcin.2022.02.012. Erratum In: JACC Cardiovasc Interv. 2022 Jul 11;15(13):1396.
Results Reference
derived

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Femoral or Radial Approach in Coronary Chronic Total Occlusion

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