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Comparison of Success Rate Between Distal Radial Approach and Radial Approach in STEMI

Primary Purpose

Distal Radial Artery Approach, ST Elevation Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Distal radial artery
Radial artery
Sponsored by
Wonju Severance Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radial Artery Approach focused on measuring Distal radial approach, ST Elevation Myocardial Infarction

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 20 years
  • ST-segment elevation myocardial infarction
  • Palpable unilateral distal radial and radial artery

Exclusion Criteria:

  • Cardiogenic shock
  • Thrombolysis before primary percutaneous coronary intervention
  • Inability to obtain written informed consent
  • Patient with ipsilateral arteriovenous fistula
  • Participation in another ongoing clinical trial
  • Pregnancy
  • Expected lifespan <12 months

    * Eligible operator criteria

  • Qualified operator who had experienced ≥ 100 cases of distal radial artery puncture

Sites / Locations

  • Kangwon National University College of MedicineRecruiting
  • Wonju Severance Christian HospitalRecruiting
  • The Catholic university of Korea Uijeongbu St. Mary's hospitalRecruiting
  • Yongin Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Distal radial artery

Radial artery

Arm Description

After subcutaneous injection of lidocaine, the distal radial artery around the bony surface area is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025" mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the distal radial artery.

After subcutaneous injection of lidocaine, the radial artery is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025" mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the radial artery.

Outcomes

Primary Outcome Measures

Puncture success rate (%)
The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group.

Secondary Outcome Measures

Success rate of coronary angiography (%)
The success rate (%) of coronary angiography will be compared between distal radial artery approach and radial artery approach group.
Success rate of percutaneous coronary intervention (%)
The success rate (%) of percutaneous coronary intervention will be compared between distal radial artery approach and radial artery approach group.
Procedure success rate (%)
The success rate (%) of final procedure will be compared between distal radial artery approach and radial artery approach group.
Bleeding complication rate (%)
The bleeding complication rate (%) will be compared between distal radial artery approach and radial artery approach group.
Total procedure time (minutes)
Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Total fluoroscopic time (minute)
Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Total fluoroscopic dose (Gray/cm2)
Scale range: 0 - 500 Gray/cm2 Lesser fluoroscopic dose is better. An averaged value will be compared and reported between two groups.
MACCE (%)
Incidence rate (%) of composite endpoints defined as all-cause death, any myocardial infarction, stroke and major bleeding
Puncture time (minute)
Scale range: 0 - 60 minutes Shorter time is considered better result. An averaged time value will be compared and reported between two groups.

Full Information

First Posted
July 17, 2018
Last Updated
May 10, 2022
Sponsor
Wonju Severance Christian Hospital
Collaborators
Hanmi Pharmaceutical co., ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03611725
Brief Title
Comparison of Success Rate Between Distal Radial Approach and Radial Approach in STEMI
Official Title
Comparison of Success Rate Between Distal Radial Approach and Radial Approach in ST-segment Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonju Severance Christian Hospital
Collaborators
Hanmi Pharmaceutical co., ltd.

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
ST-segment elevation myocardial infarction (STEMI) is an emergent disease to treat as soon as possible. 2017 ESC guidelines for the management of STEMI recommend using radial approach (RA) rather than femoral approach (FA) to reduce mortality and bleeding complications if the operators are expert for RA. Recently, Ferdinand Kiemeneij reported that distal radial approach (DRA) could be a feasible and safe route for coronary angiography (CAG) and percutaneous coronary intervention (PCI) in 70 patients. The right-handed patient could feel more comfortable in left DRA than right RA. Left DRA also could provide a better comfortable position for the operator compared to left RA. Distal radial artery is located around the anatomical snuffbox, which doesn't contain nerve and vein beside artery. Therefore, the possibility of procedure-related complications such as nerve injury or arteriovenous fistula is very low. Also, the superficial location of DRA could make easier hemostasis. There were no vascular-related complications from the report of Kiemeneij. But, the rate of puncture failure was 11%, which was higher than RA-based study (5.34% in STEMI patients of RIVAL trial, 6% in RIFLESTEACS trial and 5.8% in MATRIX trial). Nevertheless, this study was a pilot study with a small number of patients. There is no clinical study to compare the feasibility and safety for CAG and PCI between DRA and RA in patients with STEMI. Therefore, this study aimed to evaluate whether DRA is feasible and safe compared to RA in STEMI setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radial Artery Approach, ST Elevation Myocardial Infarction
Keywords
Distal radial approach, ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized either distal radial approach or radial approach.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distal radial artery
Arm Type
Active Comparator
Arm Description
After subcutaneous injection of lidocaine, the distal radial artery around the bony surface area is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025" mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the distal radial artery.
Arm Title
Radial artery
Arm Type
Placebo Comparator
Arm Description
After subcutaneous injection of lidocaine, the radial artery is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025" mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the radial artery.
Intervention Type
Procedure
Intervention Name(s)
Distal radial artery
Intervention Description
The distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
Intervention Type
Procedure
Intervention Name(s)
Radial artery
Intervention Description
The radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
Primary Outcome Measure Information:
Title
Puncture success rate (%)
Description
The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group.
Time Frame
Through procedure completion, up to 6 hours
Secondary Outcome Measure Information:
Title
Success rate of coronary angiography (%)
Description
The success rate (%) of coronary angiography will be compared between distal radial artery approach and radial artery approach group.
Time Frame
Through procedure completion, up to 6 hours
Title
Success rate of percutaneous coronary intervention (%)
Description
The success rate (%) of percutaneous coronary intervention will be compared between distal radial artery approach and radial artery approach group.
Time Frame
Through procedure completion, up to 6 hours
Title
Procedure success rate (%)
Description
The success rate (%) of final procedure will be compared between distal radial artery approach and radial artery approach group.
Time Frame
Through procedure completion, up to 6 hours
Title
Bleeding complication rate (%)
Description
The bleeding complication rate (%) will be compared between distal radial artery approach and radial artery approach group.
Time Frame
During hospitalization, up to 1 month
Title
Total procedure time (minutes)
Description
Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Time Frame
Through procedure completion, up to 6 hours
Title
Total fluoroscopic time (minute)
Description
Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Time Frame
Through procedure completion, up to 6 hours
Title
Total fluoroscopic dose (Gray/cm2)
Description
Scale range: 0 - 500 Gray/cm2 Lesser fluoroscopic dose is better. An averaged value will be compared and reported between two groups.
Time Frame
Through procedure completion, up to 6 hours
Title
MACCE (%)
Description
Incidence rate (%) of composite endpoints defined as all-cause death, any myocardial infarction, stroke and major bleeding
Time Frame
1 year
Title
Puncture time (minute)
Description
Scale range: 0 - 60 minutes Shorter time is considered better result. An averaged time value will be compared and reported between two groups.
Time Frame
Through procedure completion, up to 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 20 years ST-segment elevation myocardial infarction Palpable unilateral distal radial and radial artery Exclusion Criteria: Cardiogenic shock Thrombolysis before primary percutaneous coronary intervention Inability to obtain written informed consent Patient with ipsilateral arteriovenous fistula Participation in another ongoing clinical trial Pregnancy Expected lifespan <12 months * Eligible operator criteria Qualified operator who had experienced ≥ 100 cases of distal radial artery puncture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Won Lee, MD
Phone
+82-33-741-0920
Email
ljwcardio@yonsei.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Hwan Lee, MD
Organizational Affiliation
Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangwon National University College of Medicine
City
Chuncheon
State/Province
Gangwon-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bong-Ki Lee, MD, PhD
Email
mdbklee@kangwon.ac.kr
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-Won Lee, MD, PhD
Email
ljwcardio@yonsei.ac.kr
Facility Name
The Catholic university of Korea Uijeongbu St. Mary's hospital
City
Uijeongbu
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan Joon Kim, MD
Email
godandsci@naver.com
Facility Name
Yongin Severance Hospital
City
Yongin-si
State/Province
Gyeonggi-do
ZIP/Postal Code
449-930
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongcheol Kim, MD
Email
YONGCHEOL@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Jiwoong Roh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Success Rate Between Distal Radial Approach and Radial Approach in STEMI

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