Distal Transradial Access for Primary PCI in STEMI Patients to Prevent RAO

ST Segment Elevation Myocardial Infarction Clinical Trial

— RAPIDIII  

Official title:

Distal TransRAdial Access for Primary Percutaneous Coronary Intervention in STEMI Patients to Prevent Acute Radial Artery Occlusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461781
• Other study ID #: Beijing LH
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2022
• Source: Beijing Luhe Hospital
• Contact: Jincheng Guo
• Phone: +8613521968844
• Email: Guojcmd[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized-controlled trial to comparison of early radial artery occlusion via distal vs proximal radial artery among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.

Description:

Proximal radial artery (PRA) is recommend as the default approach for patients undergoing percutaneous coronary intervention (PCI) according 2018 ESC guidelines. However, radial artery occlusion(RAO) remains the frequent complication, precluding the future use of radial artery as access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction(STEMI) presents multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of radial artery is crucial for STEMI patients. Distal radial artery(DRA), located in anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with PRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24h via DRA when compared PRA among STEMI patients for primary PCI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 512
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• ST-segment elevation myocardial infarction for primary percuteous coronary intervention
• Palpable pulses on both access sites of the radial artery
• Informed consent

Exclusion Criteria:

• Thrombolysis before primary percutaneous coronary intervention
• Previous CABG or radio-cephalic fistula using radial artery
• Cardiogenic shock
• Severe arrhythmias
• Severe liver and kidney dysfunction
• Pregnancy
• Enrolment in another study within 1 month
• Inability to obtain written informed consent

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Intervention

Procedure:
• distal radial artery
primary percutaneous coronary intervention via distal radial aretry
• proximal radial aretry
primary percutaneous coronary intervention via proximal radial aretry

Locations

Country	Name	City	State
China	Beijing Luhe hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Luhe Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radial artery occlusion	The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.	at 24 hours after procedure
Secondary	the rate of successful puncture	Successful puncture occurs when an introducer sheath can be properly placed through the punctured artery.	Immediately post-procedurally
Secondary	puncture time	The puncture time was defined as the time interval between local anesthesia induction and successful sheath insertion.	Immediately post-procedurally
Secondary	first medical contact to device (FMC2D) time	FMC2D time was defined as the time interval between the patient's initial contact with the first physician who made the diagnosis and the first angioplasty balloon inflation.	Immediately post-procedurally
Secondary	procedural time	Procedural time defined as the time interval between local anesthesia to sheath removal.	Immediately post-procedurally
Secondary	hemostasis time	Hemostasis time was defined as the time between sheath removal to complete hemostasis.	at 24 hours after procedure
Secondary	access-related complications	Access-related complications include AV fistula formation, pseudoaneurysm, and local haematoma.	at 24 hours after procedure
Secondary	hand function	Hand function was evaluated by QuickDASH questionnaire.	1 week after procedure
Secondary	radial artery occlusion	The radial artery occlusion will be evaluated 1 month after procedure by ultrasound.	30days after procedure
Secondary	radial aretry injury	Radial aretry injury including intimal tears, dissections, perforation and thrombosis was detected by optical coherence tomography.	Immediately post-procedurally
Secondary	major adverse cardiovascular events(MACE)	MACE was defined as all-cause death, any myocardial infarction, stroke and major bleeding.	30 days after procedure