Clinical trial NCT03611725: 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
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radial Artery Approach
ST Elevation Myocardial Infarction
Keywords: Distal radial approach
ST Elevation Myocardial Infarction
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
Collaborators: name: Hanmi Pharmaceutical co., ltd.
First posted: 2018-08-02
Enrollment: 352
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized either distal radial approach or radial approach.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Puncture success rate (%)
timeFrame: Through procedure completion, up to 6 hours
Secondary outcomes:
measure: Success rate of coronary angiography (%)
timeFrame: Through procedure completion, up to 6 hours
measure: Success rate of percutaneous coronary intervention (%)
timeFrame: Through procedure completion, up to 6 hours
measure: Procedure success rate (%)
timeFrame: Through procedure completion, up to 6 hours
measure: Bleeding complication rate (%)
timeFrame: During hospitalization, up to 1 month
measure: Total procedure time (minutes)
timeFrame: Through procedure completion, up to 6 hours
measure: Total fluoroscopic time (minute)
timeFrame: Through procedure completion, up to 6 hours
measure: Total fluoroscopic dose (Gray/cm2)
timeFrame: Through procedure completion, up to 6 hours
measure: MACCE (%)
timeFrame: 1 month
measure: Puncture time (minute)
timeFrame: Through procedure completion, up to 6 hours
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University College of Medicine
state: Gangwon-do
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic university of Korea Uijeongbu St. Mary's hospital
state: Gyeonggi-do
Study officials:
affiliation: Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
name: Seung-Hwan Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: