Femoral or Radial Approach in Coronary Chronic Total Occl... | NCT03265769

Studies
Femoral or Radial Approach in Coronary Chronic Total Occlusion

NCT03265769

Sponsor

Acibadem University

Status

Completed

Last Update Posted

Sep 13, 2021Actual

Enrollment

610Actual

Phase

Not Applicable

Conditions

Chronic Coronary Occlusion

Interventions

radial access site
femoral access site

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2017Actual

Primary Completion Date

Jul 8, 2021Actual

Completion Date

Jul 8, 2021Actual

First Submitted Date

Aug 27, 2017

First Submission Date that Met QC Criteria

Aug 27, 2017

First Posted Date

Aug 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2021

Last Update Posted Date

Sep 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

610Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transradial approach	Active Comparator	target vessel revascularization via radial access site is labeled as transradial approach	Other: radial access site
Transfemoral approach	Active Comparator	target vessel revascularization via femoral access site is labeled as transfemoral approach	Other: femoral access site

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radial access site	Other	radial route	Transradial approach
femoral access site

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procedural success	Technical success without any in-hospital event	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Major access site complications	Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Acute coronary syndrome within 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sevket Gorgulu, MD	Acibadem University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Acibadem University		Istanbul			Turkey (Türkiye)
Haseki Cradiology Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35450683	Derived	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.