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

Lower Limb Ischemia Clinical Trial

— NVG-LIGHT  

Official title:

International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369809
• Other study ID #: NVG-03
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2015
• Last updated: February 26, 2017
• Start date: September 2012
• Est. completion date: January 2017

Study information

• Verified date: February 2015
• Source: Human Stem Cell Institute, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ischemia
• Lower Limb Ischemia
• Peripheral Arterial Disease

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Russian Federation	"Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution	Barnaul	Altai Region
Russian Federation	State Institution of Health Amur Region "Amur Regional Clinical Hospital"	Blagoveshchensk	Amur Region
Russian Federation	Municipal Budget Health Care Institution "City Clinical Hospital ? 8". Chelyabinsk	Chelyabinsk	Chelyabinsk Region
Russian Federation	State Health Care Institution "Regional Clinical Hospital"	Chita	Zabaikalskii Region
Russian Federation	Sverdlovsk Regional Clinical Hospital #1	Ekaterinburg	Sverdlovsk Region
Russian Federation	Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 "	Irkutsk	Irkutsk Region
Russian Federation	State Institution of Health Irkutsk "Badge of Honor" Regional Hospital	Irkutsk	Irkutsk Region
Russian Federation	Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"	Kazan	Tatarstan
Russian Federation	Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases	Kemerovo	Kemerovskaya
Russian Federation	State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital"	Kemerovo	Kemerovo Region
Russian Federation	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	Khabarovsk Region
Russian Federation	Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region	Krasnodar	Krasnodar Region
Russian Federation	Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich "	Krasnoyarsk	Krasnoyarsk Region
Russian Federation	Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo "	Moscow	Moscow Region
Russian Federation	Federal State Institution "Research Institute of Clinical and Experimental Lymphology"	Novosibirsk	Novosibirsk Region
Russian Federation	State Institution of Health of Novosibirsk Region "City Clinical Hospital #1"	Novosibirsk	Novosibirsk Region
Russian Federation	Budget Health Care Institution of Omsk Region "Regional Hospital"	Omsk	Omsk Region
Russian Federation	State Educational Institution of Higher Professional Education "Rostov State Medical University"	Rostov-na-Donu	Rostovskaya
Russian Federation	St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze	Saint Petersburg	Saint Petersburg Region
Russian Federation	State Institution of Health "Salekhard District Hospital"	Salekhard	Yamal-Nenets
Russian Federation	State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin "	Samara	Samara Region
Russian Federation	Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin	Togliatti	Samara Rigion
Russian Federation	Budgetary State Institution "Regional Hospital"	Tver	Tver Region
Russian Federation	State Institution of Health of the Tyumen region "Regional Clinical Hospital #1"	Tyumen	Khanty-Mansiysk District
Russian Federation	City Clinical Hospital # 21 Ufa	Ufa	Bashkortastan
Russian Federation	State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko "	Ulan-Ude	Buryatiya
Russian Federation	Public Health Institution "Primorsky Regional Clinical Hospital #1",	Vladivostok	Primorsky Region
Russian Federation	Voronezh State Medical Academy Named After N.N Burdenko	Voronezh	Voronezh Region
Russian Federation	State Institution of Health Yaroslavl Region "Clinical Hospital # 10"	Yaroslavl	Yaroslavl Region
Russian Federation	Republican Clinical Hospital	Yoshkar-Ola	Mari El Republic

Sponsors (1)

Lead Sponsor	Collaborator
Human Stem Cell Institute, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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 Jan 3. doi: 10.1007/s40256-016-0210-3. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the measurement of pain-free walking distance (PWD) on treadmill		3 months and 6 months after the first injection of Neovasculgen®.
Secondary	Number of adverse drug reactions (ADRs) and unexpected adverse drug reactions (UADRs)		From the first injection of Neovasculgen® until six months after the secondary injection of Neovasculgen®
Secondary	Change in the ankle-brachial index (ABI) after injection of Neovasculgen®		3 months and 6 months after the first injection of Neovasculgen®
Secondary	Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®		3 months and 6 months after the first injection of Neovasculgen®
Secondary	Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®		3 months and 6 months after the first injection of Neovasculgen®