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Clinical Trials/NCT03611725
NCT03611725
Completed
Not Applicable

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

Wonju Severance Christian Hospital3 sites in 1 country352 target enrollmentAugust 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Distal Radial Artery Approach
Sponsor
Wonju Severance Christian Hospital
Enrollment
352
Locations
3
Primary Endpoint
Puncture success rate (%)
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2018
End Date
December 13, 2023
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wonju Severance Christian Hospital
Responsible Party
Principal Investigator
Principal Investigator

Seung Hwan Lee

Professor

Wonju Severance Christian Hospital

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

Outcomes

Primary Outcomes

Puncture success rate (%)

Time Frame: 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 Outcomes

  • Success rate of coronary angiography (%)(Through procedure completion, up to 6 hours)
  • Success rate of percutaneous coronary intervention (%)(Through procedure completion, up to 6 hours)
  • Procedure success rate (%)(Through procedure completion, up to 6 hours)
  • Bleeding complication rate (%)(During hospitalization, up to 1 month)
  • Total procedure time (minutes)(Through procedure completion, up to 6 hours)
  • Total fluoroscopic time (minute)(Through procedure completion, up to 6 hours)
  • Total fluoroscopic dose (Gray/cm2)(Through procedure completion, up to 6 hours)
  • MACE (%)(1 month)
  • Puncture time (minute)(Through procedure completion, up to 6 hours)

Study Sites (3)

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