Status:
COMPLETED
Combination of InnoSEAL Plus TR Band Compared to TR Band Alone
Lead Sponsor:
Tabba Heart Institute
Conditions:
Radial Artery Occlusion
Hematoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Angiography or angioplasty are commonly now done through inserting the device through radial artery in hand i.e. trans-radial procedures. It is reported that between 2-30% of these procedures get comp...
Detailed Description
It is a prospective, randomized, open label trial with the following study hypotheses (Ha): 1. InnoSEAL+TRB is non-inferior to TRB alone in terms of the composite adverse access site outcomes includi...
Eligibility Criteria
Inclusion
- Adult patients of both gender undergoing coronary procedure using trans radial approach (diagnostic or PCI) will be included
- Both elective and hemodynamically stable, acute coronary syndrome (ACS) patients will be included.
Exclusion
- Sheath larger than 6F
- IV Heparin or GP 2b/3a inhibitors continued after the procedure
- Ongoing anticoagulation with Warfarin or Rivaroxaban or INR \> 3
- Ipsilateral AV fistula
- Barbeau's Class D
- History of RAO at baseline
- Patients unable to give consent due to clinical instability or sedation.
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
714 Patients enrolled
Trial Details
Trial ID
NCT04380883
Start Date
June 3 2020
End Date
November 30 2020
Last Update
October 20 2022
Active Locations (1)
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1
Tabba Heart Institute
Karachi, Sindh, Pakistan, 75950