A Phase 4 interventional study of Transradial primary percutaneous coronary intervention and Transfemoral primary percutaneous coronary intervention in Myocardial Infarction, Complications; Device, Vascular and Injury of Radial Artery, sponsored by Irmandade Santa Casa Misericórdia Marília. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Irmandade Santa Casa Misericórdia Marília · Phase 4, Interventional, and Treatment
Primary percutaneous coronary intervention represents the gold standard for the treatment of ST-segment-elevation acute myocardial infarction. However, periprocedural bleedings are associated with an increased risk of mortality, re-infarction, and stroke. Although the prognostic value of access site related bleeding complications is still debated, transradial approach is associated with better short-term outcomes and reduced hospital stay as compared to transfemoral approach. The investigators aimed to compare transradial approach with transfemoral approach with systematic achievement of hemostasis by the implantation of a vascular closure device in a national multicentre randomized clinical trial.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 250 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Irmandade Santa Casa Misericórdia Marília is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Transradial approach primary percutaneous coronary intervention using the TR Band device to obtain hemostasis (n=125).
Procedure: Transradial primary percutaneous coronary intervention
Transfemoral approach primary percutaneous coronary intervention using a vascular closure device to obtain hemostasis (n=125).
Procedure: Transfemoral primary percutaneous coronary intervention
Transradial coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. To achieve hemostasis in the transradial approach, a radial compression device will be applied, to maintain patent antegrade flow.
Transfemoral coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. A vascular closure device will be used to achieve hemostasis in the transfemoral approach, preceded by systematic performance of femoral angiography and maintaining absolute bed rest for 60 minutes.
Major vascular access site complications
Major vascular complications related to arterial access site will be evaluated during hospitalization by physical examination and duplex ultrassonography and include major bleeding, retroperitoneal hemorrhage, compartment syndrome, pseudoaneurysm, arteriovenous fistula, limb ischemia or need for vascular surgery repair.
Time frame: 48 hours post-procedure
Device success
The success of the device is defined as the attainment of adequate hemostasis at the end of the procedure, without the need to apply other compression methods.
Time frame: 48 hours post-procedure
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Irmandade Santa Casa Misericórdia Marília