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The impact of the selection of a dominant forearm artery on the incidence of complications after percutaneous cardiac intervention thorough radial or ulnar approach - a randomized controlled trial

The impact of the selection of a dominant forearm artery on the incidence of complications after percutaneous cardiac intervention thorough radial or ulnar approach - a randomized controlled trial - RUUS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012923
Enrollment
200
Registered
2019-01-02
Start date
2017-06-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25

Interventions

Group 1: When ulnar artery (UA) is larger than radial artery (ra). Group A patients will be randomly assigned to a subgroup where the procedure (coronary angiography) will be performed through larger

Sponsors

Centre of Postgraduate Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: age over 18 years old, qualified for coronary angiography or angioplasty, scheduled or emergency surgery

Exclusion criteria

Exclusion criteria: under 18 years of age, lack of consent to participate in the study, history of upper limb trauma or forearm deformation, occlusion of forearm arteries, lack of a perceptible pulse over RA or UA, cardiogenic shock, hemodialysis therapy, CABG (coronary artery bypass graft surgery) with bilateral left internal mammary artery (LIMA) or right internal mammary artery (RIMA) or forearm arteries

Design outcomes

Primary

MeasureTime frame
Observation In-hospital observation and 30-day follow-up from the date of discharge will record the following complications: • occurrence of ischemic brain stroke or TIA (Transient Ischemic Attack) after procedure during hospitalization, • occurrence of ischemic brain stroke or TIA (Transient Ischemic Attack) in 30-day follow-up, • occurrence of arterial occlusion (used for vascular access) during hospitalization and 30-day follow-up (based on ultrasound examination), • arterial dissection or perforation (based on postoperative angiography), • pseudoaneurysm (based on ultrasound examination), • arteriovenous fistula (based on ultrasound examination), • hematoma (classification of hematoma based on EASY scale), and • major bleeding (decrease in hemoglobin by > 5g/dL, or >15% reduction in hematocrit or other life-threatening bleeding). Clinical observation, ultrasound examination, and grip pressure measurement will be performed on the first day after surgery and 30 days after surgery. During the 30-day follow-up visit, a control measure of the grip pressure will also be performed The primary endpoint will include: • complex endpoint, including major vascular complications in the in-hospital observation (stroke, TIA, arterial occlusion, major bleeding) • complex endpoint, including major vascular complications in 30-day follow-up (stroke, TIA, arterial occlusion, major bleeding) Secondary endpoints shall include: • time of effective cannulation, • effectiveness of cannulation (insertion of sheath passage and treatment), • total fluoroscopy duration, • amount of contrast used, • change in the hand grip pressure (kg) during hospital observation, • change in the hand grip pressure (kg) during 30-day observation, • the need to change vascular access (cross-over), • occurrence of arterial thrombosis, • occurrence of hematoma (analysis of backlog extent based on EASY scale), • occurrence of pseudoaneurysm, or • occurrence of vascular fistula. Additional analysis The c

Secondary

MeasureTime frame
• time of effective cannulation, • effectiveness of cannulation (insertion of sheath passage and treatment), • total fluoroscopy duration, • amount of contrast used, • change in the hand grip pressure (kg) during hospital observation, • change in the hand grip pressure (kg) during 30-day observation, • the need to change vascular access (cross-over), • occurrence of arterial thrombosis, • occurrence of hematoma (analysis of backlog extent based on EASY scale), • occurrence of pseudoaneurysm, or • occurrence of vascular fistula.

Countries

Poland

Contacts

Public ContactPawel Lewandowski

Cardiology Department, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland

p.lewandowski@vita-medica.pl+48501352818

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026