NCT07380399Toboroz
Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty
Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty: Safety and Effect on Hand Function (ULNART)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 2.
Rövid összefoglaló (regiszter, angolul)
Coronary angiography and angioplasty are commonly performed through the radial artery at the wrist as this approach is associated with fewer bleeding complications and faster recovery. In some patients, the radial artery becomes occluded after prior procedures, requiring selection of an alternative access site for future coronary interventions. The ulnar artery is a potential alternative wrist access. However, limited data are available on the safety of using the ulnar artery in the same arm as an occluded radial artery and on the possible effects on hand strength, sensation, and daily hand function. The goal of this observational study is to evaluate the safety of transulnar access and its effect on hand function in adults with ipsilateral radial artery occlusion undergoing coronary angiography or angioplasty. The main questions addressed by the study are: * How often do serious access-related vascular or nerve complications occur? * Does hand strength, sensation, or functional use of the hand change during follow-up? * Does the ulnar artery remain patent after the procedure? The choice of vascular access site is made by the treating physician based on clinical judgment. Participants who undergo transulnar access will undergo follow-up assessments, including ultrasound evaluation of arm arteries, standardized hand function testing, and short questionnaires assessing upper-limb function. The findings of this study are expected to inform access-site selection, improve patient counseling, and support safer care for patients with radial artery occlusion undergoing coronary procedures.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 127 (tervezett)
- Első benyújtás
- 2026. jan. 21.
- Kezdés
- 2025. nov. 1.
- Elsődleges befejezés
- 2030. jan.
- Fő szponzor
- National and Kapodistrian University of Athens
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT07380399
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 127
- 2025. nov. 1. és az elsődleges befejezés (2030. jan.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- Local conditions at the intended access site, such as active infection, burn, or extensive scarring
Egyéb
- Participants meeting any of the following criteria will be excluded:
- Inadequate or absent ulnar artery flow at the intended access site on ultrasound
- Known ulnar nerve injury or neuropathy affecting the access-side upper limb
- Severe pre-existing motor or sensory dysfunction of the access-side hand that would interfere with functional assessment
- Emergency coronary procedures that preclude baseline vascular or functional assessment
- Participation in another interventional clinical study involving vascular access or intervention in the same upper limb
- Pregnancy or breastfeeding
- Life expectancy less than 6 months
Kiket keres a vizsgálat
- Participants must meet all of the following criteria to be eligible:
- Adults aged 18 years or older
- Documented radial artery occlusion in the upper limb intended for vascular access, confirmed by ultrasound or angiography
- Scheduled to undergo elective coronary angiography and/or angioplasty
- Transulnar arterial access on the same side as the occluded radial artery is selected by the treating physician
- Contralateral radial artery access is not feasible or is clinically undesirable, including for reasons such as:
- documented occlusion or severe disease of the contralateral radial artery
- unfavorable anatomy or prior failed access
- strategic preservation of the contralateral radial artery for future surgical or dialysis needs
- Adequate ulnar artery flow and anatomy for access, as assessed by pre-procedural ultrasound
- Able and willing to provide written informed consent
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Hippokratio General Hospital | Athens | Görögország | Toboroz |
| Hellenic Red Cross Hospital | Athens | Görögország | Toboroz |
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