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NCT00827853 · ClinicalTrials.gov registry record · NA
Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease
A NA study of Peripheral Vascular Disease, sponsored by North Texas Veterans Healthcare System.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 4
- Study locations
NCT00827853: Completed NA study of Peripheral Vascular Disease, sponsored by North Texas Veterans Healthcare System.
NCT00827853 is a NA study of Peripheral Vascular Disease that has completed, run by North Texas Veterans Healthcare System. The registered enrollment target is 90 participants, below the 279-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target (68% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00827853, a NA study of Peripheral Vascular Disease, has completed, sponsored by North Texas Veterans Healthcare System.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 4
- Study locations
Study Summary
Despite recent advances in stent technology and its widespread application in the treatment of peripheral vascular disease (PVD), incidences of partial or complete blockage of stent lumen (in-stent restenosis) due to in growth of cells (neo-intimal proliferation) is unacceptably high. In diabetics with long superficial femoral artery (SFA) lesions, in-stent restenosis rates are higher than in non-diabetics. Consequently interventional techniques that curtail in-stent restenosis have to be explored. Cryoplasty is a stent expansion method in which a balloon is expanded using pressurized nitrous oxide gas. As the nitrous oxide expands in the balloon it cools the surroundings to about -10 degrees C. This induces programed death (apoptosis) of the smooth muscle cells in arterial wall. The investigators hypothesize that Cryoplasty, by inducing an apoptotic smooth muscle cell response, when applied to post-dilation of nitinol self-expanding stents in the Superficial Femoral Artery (SFA) of diabetics, would lead to decreased in-stent restenosis due to decreased neointimal proliferation.
Conditions Studied
Interventions
- PROCEDURE Conventional angioplasty balloon
- PROCEDURE cryoplasty balloon
Study Locations (4)
Texas
- Dallas Veterans Hospital - Dallas
- Dallas Presbyterian Hospital - Dallas
Iowa
- Midwest Cardiovascular Research Foundation - Davenport
Oklahoma
- VA Medical Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2008-11 |
| Est. Completion | 2012-02 |
| Phase | NA |
What the finished NCT00827853 record still lists
NCT00827853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 279-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Peripheral Vascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Conventional angioplasty balloon is the first listed.
NCT00827853 reports a single indexed study location in Texas, Iowa, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT00827853 about?
NCT00827853 is a clinical study titled "Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease". Despite recent advances in stent technology and its widespread application in the treatment of peripheral vascular disease (PVD), incidences of partial or complete blockage of stent lumen (in-stent restenosis) due to in growth of cells (neo-intimal proliferation) is unacceptably high. In diabetics ...
What is the current status of trial NCT00827853?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2008-11. Estimated completion is 2012-02.
What conditions does trial NCT00827853 study?
This clinical trial studies the following conditions: Peripheral Vascular Disease.
What interventions are being tested in trial NCT00827853?
The interventions under investigation include: Conventional angioplasty balloon (PROCEDURE), cryoplasty balloon (PROCEDURE).
Who is sponsoring clinical trial NCT00827853?
This trial is sponsored by North Texas Veterans Healthcare System, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00827853 being conducted?
This trial has 4 study locations across Iowa, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Peripheral Vascular Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00827853's enrollment target sits among peer trials
90 16th of 25 higher than 10 of 25 other Peripheral Vascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Vascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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