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Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia (NVG-LIGHT)

Primary Purpose

Lower Limb Ischemia

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Neovasculgen®
Sponsored by
Human Stem Cell Institute, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb Ischemia focused on measuring Ischemia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female person aged 40 or older
  • Subject with diagnosed lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of chronic limb ischemia)
  • Signed informed consent

Exclusion Criteria:

  • Any disease that can, in the opinion of the treating physician, affect the outcome of the study
  • Patients with addictive disorders or substance abuse
  • Pregnancy or nursing
  • All other exclusion criteria listed in the summary of product characteristics (SmPC)

Sites / Locations

  • "Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution
  • State Institution of Health Amur Region "Amur Regional Clinical Hospital"
  • City Clinical Hospital # 21 Ufa
  • State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko "
  • Municipal Budget Health Care Institution "City Clinical Hospital № 8". Chelyabinsk
  • Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 "
  • State Institution of Health Irkutsk "Badge of Honor" Regional Hospital
  • State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital"
  • Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases
  • Regional State Budget Institution of Additional Professional Education "Institute of Institute for Advanced Studies of Health Professionals" of the Ministry of Health of the Khabarovsk Region
  • State Institution of Health of the Tyumen region "Regional Clinical Hospital #1"
  • Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region
  • Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich "
  • Republican Clinical Hospital
  • Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo "
  • State Institution of Health of Novosibirsk Region "City Clinical Hospital #1"
  • Federal State Institution "Research Institute of Clinical and Experimental Lymphology"
  • Budget Health Care Institution of Omsk Region "Regional Hospital"
  • Public Health Institution "Primorsky Regional Clinical Hospital #1",
  • State Educational Institution of Higher Professional Education "Rostov State Medical University"
  • St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze
  • State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin "
  • Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin
  • Sverdlovsk Regional Clinical Hospital #1
  • Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
  • Budgetary State Institution "Regional Hospital"
  • Voronezh State Medical Academy Named After N.N Burdenko
  • State Institution of Health "Salekhard District Hospital"
  • State Institution of Health Yaroslavl Region "Clinical Hospital # 10"
  • State Health Care Institution "Regional Clinical Hospital"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neovasculgen®

standard care

Arm Description

Single group prospective treatment

Outcomes

Primary Outcome Measures

Change in the measurement of pain-free walking distance (PWD) on treadmill

Secondary Outcome Measures

Number of adverse drug reactions (ADRs) and unexpected adverse drug reactions (UADRs)
Change in the ankle-brachial index (ABI) after injection of Neovasculgen®
Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®
Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®

Full Information

First Posted
February 17, 2015
Last Updated
February 26, 2017
Sponsor
Human Stem Cell Institute, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT02369809
Brief Title
Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia
Acronym
NVG-LIGHT
Official Title
International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Stem Cell Institute, Russia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with Neovasculgen®.
Detailed Description
This is an open, controlled, prospective, comparative, multicentre study design. All patients received standard conservative therapy for chronic limb ischemia without cilostazol and prostaglandins and without surgical or endovascular vessel reconstruction. Surgical and endovascular vessel reconstruction was unsuitable for all of the patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Ischemia
Keywords
Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neovasculgen®
Arm Type
Experimental
Arm Description
Single group prospective treatment
Arm Title
standard care
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Neovasculgen®
Other Intervention Name(s)
Neovasculgen
Intervention Description
Treatment according to routine clinical practice at the discretion of the treating physician. Patients receive two local intramuscular injections of Neovasculgen® at a course dose of 2.4 mg according to the summary of product characteristics (SmPC).
Primary Outcome Measure Information:
Title
Change in the measurement of pain-free walking distance (PWD) on treadmill
Time Frame
3 months and 6 months after the first injection of Neovasculgen®.
Secondary Outcome Measure Information:
Title
Number of adverse drug reactions (ADRs) and unexpected adverse drug reactions (UADRs)
Time Frame
From the first injection of Neovasculgen® until six months after the secondary injection of Neovasculgen®
Title
Change in the ankle-brachial index (ABI) after injection of Neovasculgen®
Time Frame
3 months and 6 months after the first injection of Neovasculgen®
Title
Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®
Time Frame
3 months and 6 months after the first injection of Neovasculgen®
Title
Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®
Time Frame
3 months and 6 months after the first injection of Neovasculgen®

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female person aged 40 or older Subject with diagnosed lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of chronic limb ischemia) Signed informed consent Exclusion Criteria: Any disease that can, in the opinion of the treating physician, affect the outcome of the study Patients with addictive disorders or substance abuse Pregnancy or nursing All other exclusion criteria listed in the summary of product characteristics (SmPC)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman V Deev, MD
Organizational Affiliation
+7 495 646 80 76
Official's Role
Study Director
Facility Information:
Facility Name
"Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution
City
Barnaul
State/Province
Altai Region
ZIP/Postal Code
656038
Country
Russian Federation
Facility Name
State Institution of Health Amur Region "Amur Regional Clinical Hospital"
City
Blagoveshchensk
State/Province
Amur Region
ZIP/Postal Code
675028
Country
Russian Federation
Facility Name
City Clinical Hospital # 21 Ufa
City
Ufa
State/Province
Bashkortastan
ZIP/Postal Code
450071
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko "
City
Ulan-Ude
State/Province
Buryatiya
ZIP/Postal Code
670031
Country
Russian Federation
Facility Name
Municipal Budget Health Care Institution "City Clinical Hospital № 8". Chelyabinsk
City
Chelyabinsk
State/Province
Chelyabinsk Region
ZIP/Postal Code
454071
Country
Russian Federation
Facility Name
Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 "
City
Irkutsk
State/Province
Irkutsk Region
ZIP/Postal Code
664046
Country
Russian Federation
Facility Name
State Institution of Health Irkutsk "Badge of Honor" Regional Hospital
City
Irkutsk
State/Province
Irkutsk Region
ZIP/Postal Code
664079
Country
Russian Federation
Facility Name
State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital"
City
Kemerovo
State/Province
Kemerovo Region
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases
City
Kemerovo
State/Province
Kemerovskaya
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Regional State Budget Institution of Additional Professional Education "Institute of Institute for Advanced Studies of Health Professionals" of the Ministry of Health of the Khabarovsk Region
City
Khabarovsk
State/Province
Khabarovsk Region
ZIP/Postal Code
680009
Country
Russian Federation
Facility Name
State Institution of Health of the Tyumen region "Regional Clinical Hospital #1"
City
Tyumen
State/Province
Khanty-Mansiysk District
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region
City
Krasnodar
State/Province
Krasnodar Region
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich "
City
Krasnoyarsk
State/Province
Krasnoyarsk Region
ZIP/Postal Code
660062
Country
Russian Federation
Facility Name
Republican Clinical Hospital
City
Yoshkar-Ola
State/Province
Mari El Republic
ZIP/Postal Code
424037
Country
Russian Federation
Facility Name
Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo "
City
Moscow
State/Province
Moscow Region
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
State Institution of Health of Novosibirsk Region "City Clinical Hospital #1"
City
Novosibirsk
State/Province
Novosibirsk Region
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Federal State Institution "Research Institute of Clinical and Experimental Lymphology"
City
Novosibirsk
State/Province
Novosibirsk Region
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Budget Health Care Institution of Omsk Region "Regional Hospital"
City
Omsk
State/Province
Omsk Region
ZIP/Postal Code
644111
Country
Russian Federation
Facility Name
Public Health Institution "Primorsky Regional Clinical Hospital #1",
City
Vladivostok
State/Province
Primorsky Region
ZIP/Postal Code
690091
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "Rostov State Medical University"
City
Rostov-na-Donu
State/Province
Rostovskaya
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze
City
Saint Petersburg
State/Province
Saint Petersburg Region
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin "
City
Samara
State/Province
Samara Region
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin
City
Togliatti
State/Province
Samara Rigion
ZIP/Postal Code
445023
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
State/Province
Sverdlovsk Region
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
Budgetary State Institution "Regional Hospital"
City
Tver
State/Province
Tver Region
ZIP/Postal Code
170020
Country
Russian Federation
Facility Name
Voronezh State Medical Academy Named After N.N Burdenko
City
Voronezh
State/Province
Voronezh Region
ZIP/Postal Code
394036
Country
Russian Federation
Facility Name
State Institution of Health "Salekhard District Hospital"
City
Salekhard
State/Province
Yamal-Nenets
ZIP/Postal Code
629001
Country
Russian Federation
Facility Name
State Institution of Health Yaroslavl Region "Clinical Hospital # 10"
City
Yaroslavl
State/Province
Yaroslavl Region
ZIP/Postal Code
150023
Country
Russian Federation
Facility Name
State Health Care Institution "Regional Clinical Hospital"
City
Chita
State/Province
Zabaikalskii Region
ZIP/Postal Code
672038
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
28050885
Citation
Deev R, Plaksa I, Bozo I, Isaev A. Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease. Am J Cardiovasc Drugs. 2017 Jun;17(3):235-242. doi: 10.1007/s40256-016-0210-3.
Results Reference
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Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia

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