NCT03068585

Brief Summary

In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V. Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. This study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pCMV-vegf165 gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. The study was conducted under the control of the Russian Ministry of Health and was completed in 2011. Patients enrolled in the study were subjected to a 6-month

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
5.7 years until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
Last Updated

March 3, 2017

Status Verified

June 1, 2011

Enrollment Period

1.3 years

First QC Date

June 14, 2011

Last Update Submit

February 26, 2017

Conditions

Peripheral Arterial Disease

Keywords

PADCLIstage 2a-3 of Pokrovsky-Fonteine

Outcome Measures

Primary Outcomes (1)

  • Pain-free walking distance.

    The PWD was determined using a treadmill test with reduced initial speed (1 km/h), as the majority of elderly patients were unable to perform Gardner test or its equivalents.

    6 months

Secondary Outcomes (3)

  • Ankle-brachial index

    6 months

  • Transcutaneous oximetry

    6 months

  • quality of life

    6 months

Study Arms (2)

Neovasculgen

EXPERIMENTAL

DNA encoding the 165-amino-acid isoform of human vascular endothelial growth factor (pCMV - VEGF165)

Drug: Neovasculgen (Cambiogeneplasmid)

Control

NO INTERVENTION

Control therapy

Interventions

Neovasculgen (Cambiogeneplasmid)DRUG

treatment

Also known as: Neovasculgen
Neovasculgen

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age more than 40 years;
  • a history of stable claudication for at least 3 months;
  • stage 2 to 3 chronic ischemia according to Fontaine classification (modified by A. V. Pokrovsky);
  • presence of hemodynamically significant (stenosis \>70% and/or occlusion) diffuse lesions of the interior and (or) posterior tibial arteries (distal lesion);
  • voluntary informed consent signed and dated by the patient.

You may not qualify if:

  • chronic lower limb ischemia of nonatherosclerotic genesis; stage 4 chronic ischemia according to Fontaine classification modified by A. V. Pokrovsky (ischemic ulcers and necrotic lesions);
  • severe concomitant pathology with life expectancy \<1 year;
  • infectious diseases, history of cancer, or suspected malignancy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Russian National Surgery Center by Petrovsky

Moscow, Central Russia, 119991, Russia

Location

Ryazansky State Medical University

Ryazan, Central Russia, 390026, Russia

Location

Yaroslavl State Medical Academy

Yaroslavl, Central Russia, 150000, Russia

Location

Related Publications (2)

  • Deev RV, Bozo IY, Mzhavanadze ND, Voronov DA, Gavrilenko AV, Chervyakov YV, Staroverov IN, Kalinin RE, Shvalb PG, Isaev AA. pCMV-vegf165 Intramuscular Gene Transfer is an Effective Method of Treatment for Patients With Chronic Lower Limb Ischemia. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):473-82. doi: 10.1177/1074248415574336. Epub 2015 Mar 13.

    PMID: 25770117RESULT

  • Deev R, Plaksa I, Bozo I, Mzhavanadze N, Suchkov I, Chervyakov Y, Staroverov I, Kalinin R, Isaev A. Results of 5-year follow-up study in patients with peripheral artery disease treated with PL-VEGF165 for intermittent claudication. Ther Adv Cardiovasc Dis. 2018 Sep;12(9):237-246. doi: 10.1177/1753944718786926. Epub 2018 Jul 11.

    PMID: 29996720DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2011

First Posted

March 3, 2017

Study Start

February 1, 2010

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

March 3, 2017

Record last verified: 2011-06

Data Sharing

IPD Sharing
Will not share

Locations

RU(3)