Peripheral Vascular DiseasePhase 2NCT00053716
Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
A Phase 2 study testing Liprostin [liposomal Prostaglandin E1] in people with Peripheral Vascular Disease, run by Endovasc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Liprostin [liposomal Prostaglandin E1]
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Aug 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memorial Hermann Hospital
Houston, Texas, 77030
Catey Carter, RN, 713-500-6550, catharine.v.carter@uth.tmc.edu
Carol J Underwood, RN, 713-500-6563, carol.j.underwood@uth.tmc.edu
About this study
Official title: Phase II, Single Center, Non-Controlled, Open-Label Study of Liposomal Prostaglandin E1 (Liprostin) as Adjunct Therapy With Lower Limb Angioplasty in Patients With Ischemic and Non-Ischemic Peripheral Arterial Occlusive Disease
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.
Read the detailed description
PAOD results in a decrease in arterial blood flow to the lower limb and feet with symptoms that can include, pain at rest, a numbing sensation in limb or feet, limited ability to walk before pain occurs. PAOD can occur along with diabetic ulcers.
Proposed treatment will be given at a medical center with an overnight hospital stay. Treatment includes angioplasty to open up one or two occluded arteries in a lower limb plus a drug (Liprostin) a special formulation of liposomal Prostaglandin E1,or PGE1, a natural occuring vasoactive hormone). Drug treatment is given twice to each artery to be treated, just before and after angioplasty. When angioplasty procedure is completed, a 12 hour intravenous infusion of Liprostin is given to complete the treatment procedure.
A total of 12 PAOD subjects will be enrolled in a single center: Memorial Hermann Hospital, Houston, TX.
Study will begin in February, 2003 with the last (12th) subject to be enrolled, likely by August, 20
- Conditions
- Peripheral Vascular Disease
- Being tested
- Liprostin [liposomal Prostaglandin E1]
- Keywords
- Angioplasty & PGE1 Treatment of Peripheral Vascular Disease
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liprostin [liposomal Prostaglandin E1]Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startFeb 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Endovasc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053716
- Sponsor's protocol ID
- EV 2002-05
- Other IDs
- Limb Arterial Disease Study
- Status last verified
- Mar 2004
- First submitted
- 4 Feb 2003
- Last updated
- 7 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single Center, Non-Controlled, Open-Label Study of Liposomal Prostaglandin E1 (Liprostin) as Adjunct Therapy With Lower Limb Angioplasty in Patients With Ischemic and Non-Ischemic Peripheral Arterial Occlusive Disease
- ClinicalTrials.gov ID
- NCT00053716
- Acronym / sponsor ID
- EV 2002-05
- Conditions
- Peripheral Vascular Disease
- Keywords
- Angioplasty & PGE1 Treatment of Peripheral Vascular Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants
- Lead sponsor
- EndovascIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Aug 2003
- First posted
- 6 Feb 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PAOD results in a decrease in arterial blood flow to the lower limb and feet with symptoms that can include, pain at rest, a numbing sensation in limb or feet, limited ability to walk before pain occurs. PAOD can occur along with diabetic ulcers.
Proposed treatment will be given at a medical center with an overnight hospital stay. Treatment includes angioplasty to open up one or two occluded arteries in a lower limb plus a drug (Liprostin) a special formulation of liposomal Prostaglandin E1,or PGE1, a natural occuring vasoactive hormone). Drug treatment is given twice to each artery to be treated, just before and after angioplasty. When angioplasty procedure is completed, a 12 hour intravenous infusion of Liprostin is given to complete the treatment procedure.
A total of 12 PAOD subjects will be enrolled in a single center: Memorial Hermann Hospital, Houston, TX.
Study will begin in February, 2003 with the last (12th) subject to be enrolled, likely by August, 20
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liprostin [liposomal Prostaglandin E1] | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liprostin [liposomal Prostaglandin E1] in people with Peripheral Vascular Disease, run by Endovasc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2007.