NCT00053716

Brief Summary

This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within one lower limb or the most affected of two limbs in subjects with Peripheral Arterial Occlusive Disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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, 2003

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

March 7, 2007

Status Verified

March 1, 2004

First QC Date

February 4, 2003

Last Update Submit

March 6, 2007

Conditions

Peripheral Vascular Disease

Keywords

Angioplasty & PGE1 Treatment of Peripheral Vascular Disease

Interventions

Liprostin [liposomal Prostaglandin E1]DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, 18 years and older
  • Diagnosis of Peripheral Arterial Occlusive Disease \[PAOD\]
  • Subject is a candidate for immediate angioplasty of the lower limb
  • Subject must complete 2 treadmill tests at Screen in which walking distance is limited by PAOD and not due to angina or fatigue

You may not qualify if:

  • Lower limb peripheral re-vascularization procedures in past 3 months
  • History of myocardial infarction in the past 6 months
  • Malignant disease, uncontrolled hypertension or Class III heart failure
  • Aortic occlusion, thrombosed popliteal aneurysm, severe hemorrhagic disorder, or a long iliac occlusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 4, 2003

First Posted

February 6, 2003

Study Start

February 1, 2003

Study Completion

August 1, 2003

Last Updated

March 7, 2007

Record last verified: 2004-03

Locations

US(1)