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

NCT02369809 | Completed Phase 4

• 1 other identifier: NVG-03
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 30

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®.

Conditions

Lower Limb Ischemia

Keywords

Ischemia

Outcome Measures

Primary Outcomes (1)

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

  3 months and 6 months after the first injection of Neovasculgen®.

Secondary Outcomes (4)

• 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®

• Change in the ankle-brachial index (ABI) after injection of Neovasculgen®

  3 months and 6 months after the first injection of Neovasculgen®

• Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®

  3 months and 6 months after the first injection of Neovasculgen®

• Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®

  3 months and 6 months after the first injection of Neovasculgen®

Study Arms (2)

Neovasculgen®

EXPERIMENTAL

Single group prospective treatment

Drug: Neovasculgen®

standard care

ACTIVE COMPARATOR

Drug: Neovasculgen®

Interventions

Neovasculgen® DRUG

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).

Also known as: Neovasculgen

Neovasculgen®; standard care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artgen Biotech: lead

Study Sites (30)

"Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution

Barnaul, Altayskiy Kray, 656038, Russia

Location

State Institution of Health Amur Region "Amur Regional Clinical Hospital"

Blagoveshchensk, Amur Oblast, 675028, Russia

Location

City Clinical Hospital # 21 Ufa

Ufa, Bashkortastan, 450071, Russia

Location

State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko "

Ulan-Ude, Buryatiya Republic, 670031, Russia

Location

Municipal Budget Health Care Institution "City Clinical Hospital № 8". Chelyabinsk

Chelyabinsk, Chelyabinsk Oblast, 454071, Russia

Location

Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 "

Irkutsk, Irkutsk Oblast, 664046, Russia

Location

State Institution of Health Irkutsk "Badge of Honor" Regional Hospital

Irkutsk, Irkutsk Oblast, 664079, Russia

Location

State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital"

Kemerovo, Kemerovo Oblast, 650066, Russia

Location

Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases

Kemerovo, Kemerovskaya, 650002, Russia

Location

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, 680009, Russia

Location

State Institution of Health of the Tyumen region "Regional Clinical Hospital #1"

Tyumen, Khanty-Mansiysk District, 625023, Russia

Location

Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region

Krasnodar, Krasnodarskiy Kray, 350086, Russia

Location

Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich "

Krasnoyarsk, Krasnoyarsk Region, 660062, Russia

Location

Republican Clinical Hospital

Yoshkar-Ola, Mari El Republic, 424037, Russia

Location

Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo "

Moscow, Moscow Oblast, 129110, Russia

Location

State Institution of Health of Novosibirsk Region "City Clinical Hospital #1"

Novosibirsk, Novosibirsk Oblast, 630047, Russia

Location

Federal State Institution "Research Institute of Clinical and Experimental Lymphology"

Novosibirsk, Novosibirsk Oblast, 630117, Russia

Location

Budget Health Care Institution of Omsk Region "Regional Hospital"

Omsk, Omsk Oblast, 644111, Russia

Location

Public Health Institution "Primorsky Regional Clinical Hospital #1",

Vladivostok, Primorskiy (Maritime) Kray, 690091, Russia

Location

State Educational Institution of Higher Professional Education "Rostov State Medical University"

Rostov-on-Don, Rostovskaya, 344022, Russia

Location

State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin "

Samara, Samara Oblast, 443095, Russia

Location

Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin

Tolyatti, Samara Rigion, 445023, Russia

Location

St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze

Saint Petersburg, Sankt-Peterburg, 192242, Russia

Location

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

Location

Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"

Kazan', Tatarstan Republic, 420064, Russia

Location

Budgetary State Institution "Regional Hospital"

Tver', Tver Oblast, 170020, Russia

Location

Voronezh State Medical Academy Named After N.N Burdenko

Voronezh, Voronezh Oblast, 394036, Russia

Location

State Institution of Health "Salekhard District Hospital"

Salekhard, Yamal-Nenets, 629001, Russia

Location

State Institution of Health Yaroslavl Region "Clinical Hospital # 10"

Yaroslavl, Yaroslavl Oblast, 150023, Russia

Location

State Health Care Institution "Regional Clinical Hospital"

Chita, Zabaikalskii Region, 672038, Russia

Location

Related 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 Jun;17(3):235-242. doi: 10.1007/s40256-016-0210-3.

  PMID: 28050885 BACKGROUND

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roman V Deev, MD

  +7 495 646 80 76

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 24, 2015
• Study Start: September 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 28, 2017

Record last verified: 2015-02

Locations

RU (30)