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The Safety and Efficacy of Photodynamic Therapy for Femoral Artery Stenosis

NCT00187811 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2005-12-29

No results posted yet for this study

Summary

Rstenosis is common after angioplasty of atherosclerotic disease of the femoral artery. Pilot study data suggests that adjuvant photodynamic therapy, using delta amino kleavulinic acid as a photosensitiserr is feasible and safe. This study will examine safety in a larger population and,if recruitment numbers allow, efficacy will be assessed.

Hypothesis:

ALA photodynamic therapy is safe and well tolerated as an adjuvant to angioplasty as a treatment for femoral artery atherosclerotic stenosis or occlusion. A secondary endpoint will be sought : hypothesis : PDT will reduce in restenosis rates following adjuvant photodynamic therapy compared with standard balloon angioplasty in the treatment of superficial femoral arterial disease.

Conditions

  • Atherosclerotic Narrowing of the Superficial Femoral Artery
  • Atherosclerotic Occlusion of the Superficial Femoral Artery

Interventions

PROCEDURE

Delta amino leavulinic acid photodynamic therapy

Sponsors & Collaborators

  • UCL/UCLH Clinical Research and Development Fund

    collaborator UNKNOWN

  • University College London Hospitals

    lead OTHER

Principal Investigators

  • Jean R McEwan, MB ChB FRCP · University College, London

  • Stephen Bown, PhD FRCP · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Completion
2006-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00187811 on ClinicalTrials.gov