Pilot Study of Autoarterial Remodeling of Bifurcation of the Common Carotid Artery

Stenosis, Internal Carotid Artery Clinical Trial

Official title:

The New Technique of Carotid Endarterectomy With Autoarterial Remodeling of Bifurcation of the Common Carotid Artery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027752
• Other study ID #: N-RICP-346
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: October 2018

Study information

• Verified date: August 2016
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of two methods for revascularization of the bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• stenotic lesions of the extracranial part of carotid arteries requiring surgical treatment according to national treatment guidelines (asymptomatic ICA stenosis more than 70% symptomatic ICA stenosis more than 65%)

• the length of the atherosclerotic plaques in the ICA than 1 cm

• personally signed Informed consent for participation in the study

Exclusion Criteria:

• Chronic heart failure III-IV functional class NYHA classification

• Chronic decompensated "lung" heart

• Decompensated diseases of endocrine organs (diabetes glycemia more than 10 mmol/l)

• Severe hepatic or renal insufficiency (bilirubin >80 mmol/l, creatinine >200 mmol/l)

• Polyvalent drug Allergy;

• Malignant tumor in the terminal stage with life expectancy of up to 6 months;

• Acute disruption of cerebral blood flow

• Extensive occlusion of the internal carotid artery.

• Exacerbation of systemic diseases.

• Pregnancy and lactation.

• The refusal of a patient to sign informed consent for participation in the study

Related Conditions & MeSH terms

• Stenosis, Internal Carotid Artery

Intervention

Procedure:
• Operation carotid endarterectomy with plastic of xenopericardial patch
Under local anesthesia Sol.Novocaini 0.25%, wires or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Common carotid artery cut then performed a longitudinal arteriotomy on the front of the anterior surface of the internal carotid artery. Under the visual control performs a sequence of endarterectomy of the internal carotid artery. Plastic arteriotomy performed patche of ksenoperikardial (Kemperiplas-Neo) treated with epoxy compounds.
• New method of operation ?arotid endarterectomy with autoarterial remodeling of bifurcation CCA
Under local anesthesia Sol.Novocaini 0.25%, or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Carotid glomus separated and moves downward and backward bifurcation of the common carotid artery. External carotid artery is cut off at an angle of 45º from the mouth with a portion of the common carotid artery, then performed a longitudinal arteriotomy on the front of the medial surface of the internal carotid and posterior-lateral surface of the external carotid artery. Under the visual control performs a sequence of endarterectomy of the internal and external carotid arteries. The final recovery of the arteries is performed by crosslinking of their walls with each other in a side by side type between the internal and external carotid arteries 6/0 Polypropylene thread with two needles.

Locations

Country	Name	City	State
Russian Federation	Novosibirsk Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke or TIA	according to the examination of neurologist	throughout 1 year
Secondary	Restenosis	The percentage narrowing of the lumen at the bifurcation of the carotid artery at 1 year after surgery according to the ultrasound	1 year
Secondary	Restenosis	The percentage narrowing of the lumen at the bifurcation of the carotid artery at 6 months after surgery according to the ultrasound	6 months
Secondary	paresis of the cranial nerve	Neurological status after surgical treatment according to the examination of neurologist	up to 1 weeks
Secondary	The linear flow velocity in the region of the carotid artery bifurcation	The linear velocity of blood flow in the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound	3rd day
Secondary	The linear flow velocity in the region of the carotid artery bifurcation	The linear velocity of blood flow in the bifurcation of the carotid artery after 6 months according to the ultrasound	6 months
Secondary	The linear flow velocity in the region of the carotid artery bifurcation	The linear velocity of blood flow in the bifurcation of the carotid artery after 1 year according to the ultrasound	1 year
Secondary	bleeding	30 days after surgery	1 month
Secondary	Stenosis	The percentage narrowing of the lumen at the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound	3rd day
Secondary	Oxygenation of the brain	according to transcranial oximetry	during the surgical intervention
Secondary	Oxygenation of the brain	according to transcranial oximetry	6 months
Secondary	Oxygenation of the brain	according to transcranial oximetry	1 year