Clinical trial NCT02722720: Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral
Official title: Prospective, Randomized, Single Center Study of Atherothrombotic and Thromboembolic Events After Carotid Artery Stenting Using Transfemoral and Transradial Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Atherosclerosis
Carotid Stenosis
Ischemic Attack
Stroke
Bleeding
Keywords: Carotid atherosclerosis
Carotid stenosis
Ischemic attack
Stroke
Carotid stenting
Transradial approach
Transfemoral approach
Bleeding
Thromboembolism
Embolism
Neurocognitive disorders
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting.

Detailed description: The use of transradial approach in carotid arteries stenting can significantly decrease the amount of adverse events associated with transfemoral approach such as bleeding or hematoma. Otherwise providing transradial approach is fraught with technical difficulties of common carotid artery canulation that can result in embolic complications. Taking into account the absence of studies in this area of medicine, providing investigation evaluating parameters of safety for both methodics is very actual.

Eligibility criteria: Inclusion Criteria:

* Symptomatic patients with internal carotid artery stenosis(\>50%)
* Asymptomatic patients with internal carotid artery stenosis(\>60%)
* Anatomy of internal carotid artery applicable for stent implantation and use of embolic protection device

Exclusion Criteria:

* Stroke, myocardial infarction or underwent operative treatment within 1 month
* Prior carotid artery stenting
* Cerebral vessels aneurisms/ malformations
* Subclavian artery/ brachiocephalic trunk stenosis
* Contraindications for antiplatelet or/and anticoagulation therapy

Primary outcomes:
measure: Cerebral embolism
timeFrame: during 24 hours after carotid artery stenting
Secondary outcomes:
measure: Cerebral embolism
timeFrame: intraoperative
measure: MACCE
timeFrame: during 30 days after carotid artery stenting
measure: Neurocognitive disorders
timeFrame: before and 30 days after carotid artery stenting
measure: Neurocognitive disorders
timeFrame: before and 30 days after carotid artery stenting
measure: Neurocognitive disorders
timeFrame: before and 30 days after carotid artery stenting
measure: Neurocognitive disorders
timeFrame: before and 30 days after carotid artery stenting
measure: Neurocognitive disorders
timeFrame: before and 30 days after carotid artery stenting
measure: Neurocognitive disorders
timeFrame: before and 30 days after carotid artery stenting
measure: Device success
timeFrame: intraoperative
measure: Lesion success
timeFrame: intraoperative
measure: In-hospital procedure success
timeFrame: Within 5-day hospitalization
measure: Operative access complications
timeFrame: intraoperative/ 1 day after operation
measure: Fluoroscopic time
timeFrame: intraoperative
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology
Study officials:
References: