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COMPLETED NA

Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease

NCT00827853 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 90 participants
Start Date 2008-11
Est. Completion 2012-02
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00827853

The ClinicalTrials.gov registry entry for NCT00827853 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is North Texas Veterans Healthcare System, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00827853 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Texas, Iowa, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00827853?

The interventions under investigation include: Conventional angioplasty balloon (PROCEDURE), cryoplasty balloon (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00827853?

This trial is sponsored by North Texas Veterans Healthcare System, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial