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Regional Angiogenesis with Vascular Endothelial Growth Factor (VEGF) in peripheral arterial disease: Design of the RAVE trial.
Am Heart J. 2003 Jun; 145(6):1114-8.AH

Abstract

BACKGROUND

Patients with intermittent claudication caused by infrainguinal atherosclerosis have limited pharmacologic options "Therapeutic angiogenesis" is a novel treatment approach that seeks to improve perfusion of ischemic limbs by the induction of collateral vessel formation. This trial is a phase 2 randomized double-blind placebo-controlled proof of concept trial that will use an intramuscular adenoviral gene transfer approach of vascular endothelial growth factor, 121 isoform (Ad(GV)VEGF(121.10)) to patients with severe IC caused by infrainguinal disease.

METHODS

This is a phase 2, double-blind, randomized, placebo-controlled, dose-finding, multicenter study. Patients with severe intermittent claudication caused by infrainguinal atherosclerosis predominantly involving the superficial femoral artery confirmed with imaging studies that meet inclusion criteria will be stratified on the basis of the presence or absence of diabetes mellitus and randomized in a 1:1:1 fashion to low dose (4 x 10(9) particle units), high dose (4 x 10(10) particle units), or placebo arms (35-36 patients per group). Subjects are required to have exercise-limiting IC in the index extremity during 2 qualifying exercise treadmill tests, with peak walking times between 1 and 10 minutes. A single dose of Ad(GV)VEGF(121.10) will be administered as 20 intramuscular injections throughout the area of the lower limb requiring collateralization.

RESULTS

The primary efficacy parameter for the Regional Angiogenesis With Vascular Endothelial Growth Factor (RAVE) trial is the change in peak walking time at 12 weeks compared with baseline. The sample size is expected to provide an 80% power to detect a difference of 1.5 minutes between any of the 2 treatment groups and the placebo group. Secondary efficacy parameters include claudication onset time, hemodynamic effects of therapy assessed with ankle-brachial index, assessment of physical impairment, and health-related quality of life as measured with the Walking Impairment Questionnaire and SF-36 Health Survey. All randomized patients will also be evaluated for safety.

Authors+Show Affiliations

Department of Internal Medicine, Section of Vascular Medicine, Division of Cardiology, University of Michigan Health System, Ann Arbor 48109-0273, USA. srajagop@umich.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

12796772

Citation

Rajagopalan, Sanjay, et al. "Regional Angiogenesis With Vascular Endothelial Growth Factor (VEGF) in Peripheral Arterial Disease: Design of the RAVE Trial." American Heart Journal, vol. 145, no. 6, 2003, pp. 1114-8.
Rajagopalan S, Mohler E, Lederman RJ, et al. Regional Angiogenesis with Vascular Endothelial Growth Factor (VEGF) in peripheral arterial disease: Design of the RAVE trial. Am Heart J. 2003;145(6):1114-8.
Rajagopalan, S., Mohler, E., Lederman, R. J., Saucedo, J., Mendelsohn, F. O., Olin, J., Blebea, J., Goldman, C., Trachtenberg, J. D., Pressler, M., Rasmussen, H., Annex, B. H., & Hirsch, A. T. (2003). Regional Angiogenesis with Vascular Endothelial Growth Factor (VEGF) in peripheral arterial disease: Design of the RAVE trial. American Heart Journal, 145(6), 1114-8.
Rajagopalan S, et al. Regional Angiogenesis With Vascular Endothelial Growth Factor (VEGF) in Peripheral Arterial Disease: Design of the RAVE Trial. Am Heart J. 2003;145(6):1114-8. PubMed PMID: 12796772.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regional Angiogenesis with Vascular Endothelial Growth Factor (VEGF) in peripheral arterial disease: Design of the RAVE trial. AU - Rajagopalan,Sanjay, AU - Mohler,Emile,3rd AU - Lederman,Robert J, AU - Saucedo,Jorge, AU - Mendelsohn,Farrell O, AU - Olin,Jeffrey, AU - Blebea,John, AU - Goldman,Corey, AU - Trachtenberg,Jeffrey D, AU - Pressler,Milton, AU - Rasmussen,Henrik, AU - Annex,Brian H, AU - Hirsch,Alan T, AU - ,, PY - 2003/6/11/pubmed PY - 2003/6/17/medline PY - 2003/6/11/entrez SP - 1114 EP - 8 JF - American heart journal JO - Am. Heart J. VL - 145 IS - 6 N2 - BACKGROUND: Patients with intermittent claudication caused by infrainguinal atherosclerosis have limited pharmacologic options "Therapeutic angiogenesis" is a novel treatment approach that seeks to improve perfusion of ischemic limbs by the induction of collateral vessel formation. This trial is a phase 2 randomized double-blind placebo-controlled proof of concept trial that will use an intramuscular adenoviral gene transfer approach of vascular endothelial growth factor, 121 isoform (Ad(GV)VEGF(121.10)) to patients with severe IC caused by infrainguinal disease. METHODS: This is a phase 2, double-blind, randomized, placebo-controlled, dose-finding, multicenter study. Patients with severe intermittent claudication caused by infrainguinal atherosclerosis predominantly involving the superficial femoral artery confirmed with imaging studies that meet inclusion criteria will be stratified on the basis of the presence or absence of diabetes mellitus and randomized in a 1:1:1 fashion to low dose (4 x 10(9) particle units), high dose (4 x 10(10) particle units), or placebo arms (35-36 patients per group). Subjects are required to have exercise-limiting IC in the index extremity during 2 qualifying exercise treadmill tests, with peak walking times between 1 and 10 minutes. A single dose of Ad(GV)VEGF(121.10) will be administered as 20 intramuscular injections throughout the area of the lower limb requiring collateralization. RESULTS: The primary efficacy parameter for the Regional Angiogenesis With Vascular Endothelial Growth Factor (RAVE) trial is the change in peak walking time at 12 weeks compared with baseline. The sample size is expected to provide an 80% power to detect a difference of 1.5 minutes between any of the 2 treatment groups and the placebo group. Secondary efficacy parameters include claudication onset time, hemodynamic effects of therapy assessed with ankle-brachial index, assessment of physical impairment, and health-related quality of life as measured with the Walking Impairment Questionnaire and SF-36 Health Survey. All randomized patients will also be evaluated for safety. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/12796772/Regional_Angiogenesis_with_Vascular_Endothelial_Growth_Factor__VEGF__in_peripheral_arterial_disease:_Design_of_the_RAVE_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002870303001029 DB - PRIME DP - Unbound Medicine ER -