Angioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery

?hronic Ischemia of the Lower Extremities Clinical Trial

— ATRFPA  

Official title:

A Pilot Prospective Study of Two Methods of Revascularization of Tibial Arteries: Angioplasty Tibial Arteries, and Angioplasty Tibial Artery, Augmented by Radio Frequency Denervation Popliteal Artery in Patients With Steno-occlusive Lesion of the Tibial Arteries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02825446
• Other study ID #: N-RICP-873
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 2020

Study information

• Verified date: May 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will remove the spasm with macro and microcirculatory blood flow, which increases revascularization patency of tibial arteries.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 2020
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Chronic lower limb ischemia 3-6 degree by Rutherford;

• Stenosis or occlusion of no more than 2 tibial arteries;

• Stenosis of the tibial arteries more than 70 %;

• Duration stenosis or occlusion no more than 70 mm;

Exclusion Criteria:

• Diabetes mellitus type 2

• Occlusion or stenosis of all tibial arteries

• Expressed calcification of tibial arteries angioplasty tolerant

• Hemodynamically significant stenosis of the popliteal artery;

• Chronic heart failure of III-IV functional class by NYHA classification;

• Decompensated chronic "pulmonary" heart;

• Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);

• Polyvalent drug allergy;

• Cancer in the terminal stage with a life expectancy less than 6 months;

• Patient refusal to participate or continue to participate in the study;

Related Conditions & MeSH terms

• ?hronic Ischemia of the Lower Extremities
• Atherosclerosis
• Atherosclerosis of the Tibial Arteries
• Ischemia
• Lesion no More Than Two Tibial Arteries
• Steno-occlusive Lesion of the Tibial Arteries

Intervention

Procedure:
• angioplasty tibial arteries
Under local anesthesia using the standard endovascular access and renders the affected arterial segment. Are stenosis or occlusion of the artery, the hydrophilic guide. Occlusion or subintimal perform transluminal recanalization of the artery. Then do balloon angioplastic stenosis or occlusion. Drug therapy includes the administration of aspirin before the procedure (160-300 mg/day) starting at least one day, and heparin during the procedure (5000 IU intravenously). After the procedure, all patients are administered aspirin (100 mg daily) for a long time.
• angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"
Under local anesthesia using the standard endovascular access and renders the affected arterial segment. Are stenosis or occlusion of the artery, the hydrophilic guide. Occlusion or subintimal perform transluminal recanalization of the artery. Then do balloon angioplastic stenosis or occlusion. Then in 3 portion of the popliteal artery starts ablation by the use "Vessix Renal Denervation System Balloon" performed radiofrequency denervation. After removal of the balloon, control angiography is performed. Drug therapy includes the administration of aspirin before the procedure (160-300 mg/day) starting at least one day, and heparin during the procedure (5000 IU intravenously). After the procedure, all patients are administered aspirin (100 mg daily) for a long time.

Locations

Country	Name	City	State
Russian Federation	NRICP	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	the absence of thrombosis or stenosis of the popliteal artery	during the whole period of observation, confirmation of patency of the arterial ultrasound of the operated segment as well as such parameters as flow rate, presence of stenosis (%) or thrombosis	12 mounth after intervention
Secondary	Primary patency after intervention	during the whole period of observation, confirmation of patency of the arterial ultrasound of the operated segment as well as such parameters as flow rate, presence of stenosis (%) or thrombosis	12-mounth after intervention
Secondary	Secondary patency after intervention	during the whole period of observation, confirmation of patency of the arterial ultrasound of the operated segment as well as such parameters as flow rate, presence of stenosis (%) or thrombosis	12-mounth after intervention
Secondary	Number of participants with limb salvage	Number of participants with limb salvage	12 mounth after intervention
Secondary	Laser Doppler Flowmetry	to assess the microcirculation of the lower limbs use such parameters as: the time until the maximal post-occlusive blood flow; maximal post-occlusive blood flow; post-occlusive blood flow increase of	12 mounth after intervention
Secondary	Transcutaneous oxygen tension	to assess the microcirculation of the lower limbs use a level transcutaneous oxygen tension (%)	12 mounth after intervention