NVG-LIGHT: Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia
Sponsor
Human Stem Cell Institute, Russia (Other)
Overall Status
Completed
CT.gov ID
NCT02369809
Collaborator
(none)
210
30
2
52
7
0.1
Study Details
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®.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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
Study Design
Study Type:
Interventional
Actual Enrollment
:
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease
Study Start Date
:
Sep 1, 2012
Actual Primary Completion Date
:
Jan 1, 2017
Actual Study Completion Date
:
Jan 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Neovasculgen® Single group prospective treatment |
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).
Other Names:
|
| Active Comparator: standard care
|
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).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in the measurement of pain-free walking distance (PWD) on treadmill [3 months and 6 months after the first injection of Neovasculgen®.]
Secondary Outcome Measures
- 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®]
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | "Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution | Barnaul | Altai Region | Russian Federation | 656038 |
| 2 | State Institution of Health Amur Region "Amur Regional Clinical Hospital" | Blagoveshchensk | Amur Region | Russian Federation | 675028 |
| 3 | City Clinical Hospital # 21 Ufa | Ufa | Bashkortastan | Russian Federation | 450071 |
| 4 | State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko " | Ulan-Ude | Buryatiya | Russian Federation | 670031 |
| 5 | Municipal Budget Health Care Institution "City Clinical Hospital № 8". Chelyabinsk | Chelyabinsk | Chelyabinsk Region | Russian Federation | 454071 |
| 6 | Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 " | Irkutsk | Irkutsk Region | Russian Federation | 664046 |
| 7 | State Institution of Health Irkutsk "Badge of Honor" Regional Hospital | Irkutsk | Irkutsk Region | Russian Federation | 664079 |
| 8 | State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital" | Kemerovo | Kemerovo Region | Russian Federation | 650066 |
| 9 | Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases | Kemerovo | Kemerovskaya | Russian Federation | 650002 |
| 10 | 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 | 680009 |
| 11 | State Institution of Health of the Tyumen region "Regional Clinical Hospital #1" | Tyumen | Khanty-Mansiysk District | Russian Federation | 625023 |
| 12 | Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region | Krasnodar | Krasnodar Region | Russian Federation | 350086 |
| 13 | Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich " | Krasnoyarsk | Krasnoyarsk Region | Russian Federation | 660062 |
| 14 | Republican Clinical Hospital | Yoshkar-Ola | Mari El Republic | Russian Federation | 424037 |
| 15 | Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo " | Moscow | Moscow Region | Russian Federation | 129110 |
| 16 | State Institution of Health of Novosibirsk Region "City Clinical Hospital #1" | Novosibirsk | Novosibirsk Region | Russian Federation | 630047 |
| 17 | Federal State Institution "Research Institute of Clinical and Experimental Lymphology" | Novosibirsk | Novosibirsk Region | Russian Federation | 630117 |
| 18 | Budget Health Care Institution of Omsk Region "Regional Hospital" | Omsk | Omsk Region | Russian Federation | 644111 |
| 19 | Public Health Institution "Primorsky Regional Clinical Hospital #1", | Vladivostok | Primorsky Region | Russian Federation | 690091 |
| 20 | State Educational Institution of Higher Professional Education "Rostov State Medical University" | Rostov-na-Donu | Rostovskaya | Russian Federation | 344022 |
| 21 | St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze | Saint Petersburg | Saint Petersburg Region | Russian Federation | 192242 |
| 22 | State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin " | Samara | Samara Region | Russian Federation | 443095 |
| 23 | Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin | Togliatti | Samara Rigion | Russian Federation | 445023 |
| 24 | Sverdlovsk Regional Clinical Hospital #1 | Ekaterinburg | Sverdlovsk Region | Russian Federation | 620102 |
| 25 | Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan" | Kazan | Tatarstan | Russian Federation | 420064 |
| 26 | Budgetary State Institution "Regional Hospital" | Tver | Tver Region | Russian Federation | 170020 |
| 27 | Voronezh State Medical Academy Named After N.N Burdenko | Voronezh | Voronezh Region | Russian Federation | 394036 |
| 28 | State Institution of Health "Salekhard District Hospital" | Salekhard | Yamal-Nenets | Russian Federation | 629001 |
| 29 | State Institution of Health Yaroslavl Region "Clinical Hospital # 10" | Yaroslavl | Yaroslavl Region | Russian Federation | 150023 |
| 30 | State Health Care Institution "Regional Clinical Hospital" | Chita | Zabaikalskii Region | Russian Federation | 672038 |
Sponsors and Collaborators
- Human Stem Cell Institute, Russia
Investigators
- Study Director: Roman V Deev, MD, +7 495 646 80 76
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Human Stem Cell Institute, Russia
ClinicalTrials.gov Identifier:
NCT02369809
Other Study ID Numbers:
- NVG-03
First Posted:
Feb 24, 2015
Last Update Posted:
Feb 28, 2017
Last Verified:
Feb 1, 2015