Recruiting
Phase 2

Liprostin with Angioplasty

Sponsor:

Endovasc

Code:

NCT00053716

Conditions

Peripheral Vascular Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Liprostin [liposomal Prostaglandin E1]

Study Details

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.

Conditions

Peripheral Vascular Disease

Study ID

NCT00053716

Start date

Feb, 2003

Status verified date

Mar, 2004

Completion date

Aug, 2003

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

12 participants

Allocation

Non randomized

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Liprostin [liposomal Prostaglandin E1]

Central Contacts and Locations

Locations

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Catey Carter, RN

713-500-6550catharine.v.carter@uth.tmc.edu

Carol J Underwood, RN

713-500-6563carol.j.underwood@uth.tmc.edu

Principal Investigator:

Richard W. Smalling, M.D., Ph.D

More Information

Sponsor

Endovasc

Last update posted

Mar 7, 2007

Last verified

Mar, 2004

Keywords

  • Angioplasty & PGE1 Treatment of Peripheral Vascular Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endovasc on 2007-03-07.