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

ST Elevation Myocardial Infarction Clinical Trial

Official title:

Comparison of Success Rate Between Distal Radial Approach and Radial Approach in ST-segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611725
• Other study ID #: DRAMI
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: December 13, 2023

Study information

• Verified date: December 2023
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: December 13, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radial Artery Approach
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• Distal radial artery
The distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
• Radial artery
The radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.

Locations

Country	Name	City	State
Korea, Republic of	Kangwon National University College of Medicine	Chuncheon	Gangwon-do
Korea, Republic of	The Catholic university of Korea Uijeongbu St. Mary's hospital	Uijeongbu	Gyeonggi-do
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon-do
Korea, Republic of	Yongin Severance Hospital	Yongin-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital	Hanmi Pharmaceutical co., ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Puncture success rate (%)	The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group.	Through procedure completion, up to 6 hours
Secondary	Success rate of coronary angiography (%)	The success rate (%) of coronary angiography will be compared between distal radial artery approach and radial artery approach group.	Through procedure completion, up to 6 hours
Secondary	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.	Through procedure completion, up to 6 hours
Secondary	Procedure success rate (%)	The success rate (%) of final procedure will be compared between distal radial artery approach and radial artery approach group.	Through procedure completion, up to 6 hours
Secondary	Bleeding complication rate (%)	The bleeding complication rate (%) will be compared between distal radial artery approach and radial artery approach group.	During hospitalization, up to 1 month
Secondary	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.	Through procedure completion, up to 6 hours
Secondary	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.	Through procedure completion, up to 6 hours
Secondary	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.	Through procedure completion, up to 6 hours
Secondary	MACCE (%)	Incidence rate (%) of composite endpoints defined as all-cause death, any myocardial infarction, stroke and major bleeding	1 year
Secondary	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.	Through procedure completion, up to 6 hours