Comparison of Success Rate Between Distal Radial Approach and Radial Approach in STEMI
- Conditions
- ST Elevation Myocardial InfarctionDistal Radial Artery Approach
- Interventions
- Procedure: Distal radial arteryProcedure: Radial artery
- Registration Number
- NCT03611725
- Lead Sponsor
- Wonju Severance Christian Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
- Age ≥ 20 years
- ST-segment elevation myocardial infarction
- Palpable unilateral distal radial and radial artery
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Distal radial artery Distal radial artery 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. Radial artery 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.
- Primary Outcome Measures
Name Time Method Puncture success rate (%) Through procedure completion, up to 6 hours The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group.
- Secondary Outcome Measures
Name Time Method Success rate of coronary angiography (%) Through procedure completion, up to 6 hours The success rate (%) of coronary angiography will be compared between distal radial artery approach and radial artery approach group.
Bleeding complication rate (%) During hospitalization, up to 1 month The bleeding complication rate (%) will be compared between distal radial artery approach and radial artery approach group.
MACCE (%) 1 month Incidence rate (%) of composite endpoints defined as all-cause death, any myocardial infarction, stroke and major bleeding
Puncture time (minute) Through procedure completion, up to 6 hours Scale range: 0 - 60 minutes Shorter time is considered better result. An averaged time value will be compared and reported between two groups.
Success rate of percutaneous coronary intervention (%) Through procedure completion, up to 6 hours The success rate (%) of percutaneous coronary intervention will be compared between distal radial artery approach and radial artery approach group.
Procedure success rate (%) Through procedure completion, up to 6 hours The success rate (%) of final procedure will be compared between distal radial artery approach and radial artery approach group.
Total fluoroscopic dose (Gray/cm2) Through procedure completion, up to 6 hours Scale range: 0 - 500 Gray/cm2 Lesser fluoroscopic dose is better. An averaged value will be compared and reported between two groups.
Total fluoroscopic time (minute) Through procedure completion, up to 6 hours 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 procedure time (minutes) Through procedure completion, up to 6 hours Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Trial Locations
- Locations (3)
Kangwon National University College of Medicine
🇰🇷Chuncheon, Gangwon-do, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Gangwon-do, Korea, Republic of
The Catholic university of Korea Uijeongbu St. Mary's hospital
🇰🇷Uijeongbu, Gyeonggi-do, Korea, Republic of