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出境医 / 临床实验 / Stella Supera Siberia

Stella Supera Siberia

Study Description
Brief Summary:

Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).

The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criterias, the possible influence of calcifications and the quality of life of patients


Condition or disease Intervention/treatment Phase
Atherosclerosis Peripheral Arterial Disease Superficial Femoral Artery Occlusion Device: Endovascular treatment for PAD Not Applicable

Detailed Description:

Patient will be recruiting during 1 year. Patient will be followed in the study during 2 years. Pre-operative exams are collected. Patients are asked to give their oral authorization to participate in the study by their surgeon.

Patient can be included up to the next day of the intervention.

Endovascular treatment of femoropopliteal lesion with SuperA stents :

Intervention will be achieved in operative room, under local anesthesia and sedation or general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for TASC C or D lesion involving the superficial femoral and/or popliteal arteries.

The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm diameter more than the stent to be implanted.

A control arteriography will be done before the implantation of the stent and at the end of the intervention to assess the success of the procedure.

If needed, endovascular treatment could be realized on the inflow or outflow in the same time.

Patient follow-up :

Patient follow-up is performed at 1, 6, 12 and 24 months. Follow-up will systematically include a clinical evaluation and a duplex scan with the ankle brachial index (ABI).

The x-rays and the quality of life questionnaire will be done at 1, 12 and 24 months.

All clinical surveillance events, complications and re-hospitalizations will be collected.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : May 13, 2022
Estimated Study Completion Date : May 13, 2022
Arms and Interventions
Arm Intervention/treatment
Endovascular treatment for PAD
Single group study (1 arm)
Device: Endovascular treatment for PAD
Long femoropopliteal stenting with SuperA devices

Outcome Measures
Primary Outcome Measures :
  1. Changes in chronic lower limb ischemia at 12 months follow-up [ Time Frame: 12 months ]

    Number of cases of improvement of at least 1 category of Rutherford classification for claudicants.

    Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia



Secondary Outcome Measures :
  1. Changes in chronic lower limb ischemia at 24 months follow-up [ Time Frame: 24 months ]

    Number of cases of improvement of at least 1 category of Rutherford classification for claudicants.

    Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia


  2. Major adverse cardiovascular events [ Time Frame: 24 months ]
    Number of cases of MACE at 24 months follow-up

  3. Major adverse limb events [ Time Frame: 24 months ]
    Number of cases of MALE at 24 months follow-up

  4. Limb salvage rate [ Time Frame: 24 months ]
    Number of cases of limb salvage at 24 months follow-up

  5. Changes in ankle-brachial index [ Time Frame: 24 months ]
    Changes in mean of ankle-brachial index after procedure at 24 months follow-up

  6. Primary patency [ Time Frame: 24 months ]
    Primary patency rate at 24 months follow-up

  7. Secondary patency [ Time Frame: 24 months ]
    Secondary patency rate at 24 months follow-up

  8. Restenosis rate [ Time Frame: 24 months ]
    Number of cases of significant restenosis (more, than 50%) in stenting arterial segment

  9. Thrombosis rate [ Time Frame: 24 months ]
    Number of cases of thrombosis in stenting arterial segment

  10. Changes in the patients quality of life [ Time Frame: 1, 12, 24 months ]
    Changes in mean of EQ5D-3L questionnaire units after procedure


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic PAD, Rutherford 2 to 6
  • Atherosclerotic femoropopliteal lesion TASC C or D (on CT scan or arteriography)
  • De novo femoropopliteal lesion
  • Patient informed of the study and oral authorization collected

Exclusion Criteria:

  • Under-age patient
  • Patient of age, but under legal guardianship or care
  • Potentially pregnant women
  • Patients do not understand the French language
  • Asymptomatic lesion
  • Acute ischemia or acute thrombosis
  • Lesion already treated
  • No-atherosclerotic disease
  • hemostasis disorder
  • severe comorbidity with life expectancy less than 2 years
  • contraindication of antiplatelet (dual antiplatelet therapy required during at least 2 month post-intervention)
  • patient participating in a clinical trial likely to interfer
  • Comorbidity or other, according investigator, that may interfere with the conduct of the study
  • lesion near to an aneurysm
  • Patient follow-up impossible
  • Patient refuse to participate
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Alexander A Gostev +73833476066 a_gostev@meshalkin.ru

Locations
Layout table for location information
Russian Federation
Alexander A Gostev Recruiting
Novosibirsk, Novosibirskaya Obl, Russian Federation, 630005
Contact: Alexander A Gostev    5677766    a_gostev@meshalkin.ru   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Abbott
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date May 13, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Changes in chronic lower limb ischemia at 12 months follow-up [ Time Frame: 12 months ]
Number of cases of improvement of at least 1 category of Rutherford classification for claudicants. Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Changes in chronic lower limb ischemia at 24 months follow-up [ Time Frame: 24 months ]
    Number of cases of improvement of at least 1 category of Rutherford classification for claudicants. Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia
  • Major adverse cardiovascular events [ Time Frame: 24 months ]
    Number of cases of MACE at 24 months follow-up
  • Major adverse limb events [ Time Frame: 24 months ]
    Number of cases of MALE at 24 months follow-up
  • Limb salvage rate [ Time Frame: 24 months ]
    Number of cases of limb salvage at 24 months follow-up
  • Changes in ankle-brachial index [ Time Frame: 24 months ]
    Changes in mean of ankle-brachial index after procedure at 24 months follow-up
  • Primary patency [ Time Frame: 24 months ]
    Primary patency rate at 24 months follow-up
  • Secondary patency [ Time Frame: 24 months ]
    Secondary patency rate at 24 months follow-up
  • Restenosis rate [ Time Frame: 24 months ]
    Number of cases of significant restenosis (more, than 50%) in stenting arterial segment
  • Thrombosis rate [ Time Frame: 24 months ]
    Number of cases of thrombosis in stenting arterial segment
  • Changes in the patients quality of life [ Time Frame: 1, 12, 24 months ]
    Changes in mean of EQ5D-3L questionnaire units after procedure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stella Supera Siberia
Official Title  ICMJE Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia
Brief Summary

Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).

The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criterias, the possible influence of calcifications and the quality of life of patients

Detailed Description

Patient will be recruiting during 1 year. Patient will be followed in the study during 2 years. Pre-operative exams are collected. Patients are asked to give their oral authorization to participate in the study by their surgeon.

Patient can be included up to the next day of the intervention.

Endovascular treatment of femoropopliteal lesion with SuperA stents :

Intervention will be achieved in operative room, under local anesthesia and sedation or general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for TASC C or D lesion involving the superficial femoral and/or popliteal arteries.

The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm diameter more than the stent to be implanted.

A control arteriography will be done before the implantation of the stent and at the end of the intervention to assess the success of the procedure.

If needed, endovascular treatment could be realized on the inflow or outflow in the same time.

Patient follow-up :

Patient follow-up is performed at 1, 6, 12 and 24 months. Follow-up will systematically include a clinical evaluation and a duplex scan with the ankle brachial index (ABI).

The x-rays and the quality of life questionnaire will be done at 1, 12 and 24 months.

All clinical surveillance events, complications and re-hospitalizations will be collected.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atherosclerosis
  • Peripheral Arterial Disease
  • Superficial Femoral Artery Occlusion
Intervention  ICMJE Device: Endovascular treatment for PAD
Long femoropopliteal stenting with SuperA devices
Study Arms  ICMJE Endovascular treatment for PAD
Single group study (1 arm)
Intervention: Device: Endovascular treatment for PAD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 13, 2022
Estimated Primary Completion Date May 13, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Symptomatic PAD, Rutherford 2 to 6
  • Atherosclerotic femoropopliteal lesion TASC C or D (on CT scan or arteriography)
  • De novo femoropopliteal lesion
  • Patient informed of the study and oral authorization collected

Exclusion Criteria:

  • Under-age patient
  • Patient of age, but under legal guardianship or care
  • Potentially pregnant women
  • Patients do not understand the French language
  • Asymptomatic lesion
  • Acute ischemia or acute thrombosis
  • Lesion already treated
  • No-atherosclerotic disease
  • hemostasis disorder
  • severe comorbidity with life expectancy less than 2 years
  • contraindication of antiplatelet (dual antiplatelet therapy required during at least 2 month post-intervention)
  • patient participating in a clinical trial likely to interfer
  • Comorbidity or other, according investigator, that may interfere with the conduct of the study
  • lesion near to an aneurysm
  • Patient follow-up impossible
  • Patient refuse to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexander A Gostev +73833476066 a_gostev@meshalkin.ru
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951727
Other Study ID Numbers  ICMJE NSK001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meshalkin Research Institute of Pathology of Circulation
Study Sponsor  ICMJE Meshalkin Research Institute of Pathology of Circulation
Collaborators  ICMJE Abbott
Investigators  ICMJE Not Provided
PRS Account Meshalkin Research Institute of Pathology of Circulation
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP