Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia
NCT ID: NCT02369809
Last Updated: 2017-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
210 participants
INTERVENTIONAL
2012-09-30
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neovasculgen®
Single group prospective treatment
Neovasculgen®
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).
standard care
Neovasculgen®
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).
Interventions
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Neovasculgen®
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject with diagnosed lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of chronic limb ischemia)
* Signed informed consent
Exclusion Criteria
* Patients with addictive disorders or substance abuse
* Pregnancy or nursing
40 Years
ALL
No
Sponsors
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Artgen Biotech
OTHER
Responsible Party
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Principal Investigators
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Roman V Deev, MD
Role: STUDY_DIRECTOR
+7 495 646 80 76
Locations
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"Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution
Barnaul, Altayskiy Kray, Russia
State Institution of Health Amur Region "Amur Regional Clinical Hospital"
Blagoveshchensk, Amur Oblast, Russia
City Clinical Hospital # 21 Ufa
Ufa, Bashkortastan, Russia
State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko "
Ulan-Ude, Buryatiya Republic, Russia
Municipal Budget Health Care Institution "City Clinical Hospital № 8". Chelyabinsk
Chelyabinsk, Chelyabinsk Oblast, Russia
Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 "
Irkutsk, Irkutsk Oblast, Russia
State Institution of Health Irkutsk "Badge of Honor" Regional Hospital
Irkutsk, Irkutsk Oblast, Russia
State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital"
Kemerovo, Kemerovo Oblast, Russia
Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases
Kemerovo, Kemerovskaya, Russia
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
Khabarovsk, Khabarovskiy Kray, Russia
State Institution of Health of the Tyumen region "Regional Clinical Hospital #1"
Tyumen, Khanty-Mansiysk District, Russia
Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region
Krasnodar, Krasnodarskiy Kray, Russia
Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich "
Krasnoyarsk, Krasnoyarsk Region, Russia
Republican Clinical Hospital
Yoshkar-Ola, Mari El Republic, Russia
Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo "
Moscow, Moscow Oblast, Russia
State Institution of Health of Novosibirsk Region "City Clinical Hospital #1"
Novosibirsk, Novosibirsk Oblast, Russia
Federal State Institution "Research Institute of Clinical and Experimental Lymphology"
Novosibirsk, Novosibirsk Oblast, Russia
Budget Health Care Institution of Omsk Region "Regional Hospital"
Omsk, Omsk Oblast, Russia
Public Health Institution "Primorsky Regional Clinical Hospital #1",
Vladivostok, Primorskiy (Maritime) Kray, Russia
State Educational Institution of Higher Professional Education "Rostov State Medical University"
Rostov-on-Don, Rostovskaya, Russia
State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin "
Samara, Samara Oblast, Russia
Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin
Tolyatti, Samara Rigion, Russia
St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze
Saint Petersburg, Sankt-Peterburg, Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, Sverdlovsk Oblast, Russia
Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
Kazan', Tatarstan Republic, Russia
Budgetary State Institution "Regional Hospital"
Tver', Tver Oblast, Russia
Voronezh State Medical Academy Named After N.N Burdenko
Voronezh, Voronezh Oblast, Russia
State Institution of Health "Salekhard District Hospital"
Salekhard, Yamal-Nenets, Russia
State Institution of Health Yaroslavl Region "Clinical Hospital # 10"
Yaroslavl, Yaroslavl Oblast, Russia
State Health Care Institution "Regional Clinical Hospital"
Chita, Zabaikalskii Region, Russia
Countries
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References
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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.
Other Identifiers
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NVG-03
Identifier Type: -
Identifier Source: org_study_id
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