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Angioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery (ATRFPA)

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ClinicalTrials.gov Identifier: NCT02825446
Recruitment Status : Terminated (a significant number of patients were not selected)
First Posted : July 7, 2016
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Brief 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.

Condition or disease Intervention/treatment Phase
Сhronic Ischemia of the Lower Extremities Atherosclerosis of the Tibial Arteries Lesion no More Than Two Tibial Arteries Steno-occlusive Lesion of the Tibial Arteries Procedure: angioplasty tibial arteries Procedure: angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon" Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Active Comparator: angioplasty tibial arteries 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.


Experimental: radio frequency denervation popliteal artery by the use
radio frequency denervation popliteal artery "Vessix Renal Denervation System Balloon"
Procedure: 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.





Primary Outcome Measures :
  1. the absence of thrombosis or stenosis of the popliteal artery [ Time Frame: 12 mounth 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


Secondary Outcome Measures :
  1. Primary patency after intervention [ Time Frame: 12-mounth 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

  2. Secondary patency after intervention [ Time Frame: 12-mounth 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

  3. Number of participants with limb salvage [ Time Frame: 12 mounth after intervention ]
    Number of participants with limb salvage

  4. Laser Doppler Flowmetry [ Time Frame: 12 mounth after intervention ]

    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

  5. Transcutaneous oxygen tension [ Time Frame: 12 mounth after intervention ]
    to assess the microcirculation of the lower limbs use a level transcutaneous oxygen tension (%)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825446


Locations
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Russian Federation
NRICP
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
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Study Director: Andrey Karpenko Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02825446    
Other Study ID Numbers: N-RICP-873
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: May 2020
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
radio frequency denervation
tibial arteries
atherosclerosis of the peripheral arteries
Additional relevant MeSH terms:
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Atherosclerosis
Ischemia
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases