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NCT03671655 · ClinicalTrials.gov registry record · NA
Excellence in Peripheral Arterial Disease Treatment of Superficial Femoral Artery Disease With Drug-eluting Stents
A NA study, sponsored by North Texas Veterans Healthcare System.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT03671655 is a NA study that was terminated before completion, run by North Texas Veterans Healthcare System. The registered enrollment target is 4 participants.
The verdict
NCT03671655, a NA study, was terminated before completion, sponsored by North Texas Veterans Healthcare System.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
The superficial femoral artery (SFA) is frequently involved in atherosclerosis and is the most common target of lower extremity endovascular procedures performed in patients with claudication. Endovascular treatment of SFA is challenging, given its exceptional predisposition to atherosclerosis and its exposure to extreme mechanical forces of extension, compression, torsion and flexion. The SFA is located in a fibro-muscular canal, follows a tortuous course and is considered a 'hostile' location for endovascular procedures, especially stents due to the risk of stent fracture. On the other hand, durability of balloon angioplasty in the SFA is dismal (25% patency at 1 year). Therefore, Nitinol (a metal alloy of nickel and titanium) stent implantation is the mainstay of endovascular SFA interventions when balloon angioplasty (PTA) leads to sub-optimal results during a procedure. It is used in over 70% of all cases and in nearly 100% of all femoro-popliteal (FP) CTO (chronic total occlusions) and long (≥60 mm) interventions. Endovascular treatment of SFA is challenging and restenosis is the most common cause for the lack of durability of a SFA peripheral vascular interventional procedure.5 Restenosis rates of SFA bare metal (nitinol) stents or BMS at 1 year exceeds 50% for lesions ≥60 mm in length or CTO. Stent based treatment of the SFA may not offer any additional advantage for short non-CTO (\<60 mm) lesions compared to PTA. In a recent study, primarily comparing drug-eluting stents (DES) to balloon angioplasty in the SFA, 12 month patency rates were 83.1% and 32.8%, respectively for DES and balloon angioplasty arms. However, there are no head-to head studies randomized studies comparing DES and BMS in the SFA. Thus, endovascular SFA intervention in patients with symptomatic PAD is an area of urgent need for high-quality evidence as volume of these procedures continues to rise exponentially in the U.S. and around the world, largely on the basis of insufficient evidenc
Interventions
- DEVICE Bare metal stent
- DEVICE Drug-eluting stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03671655
The ClinicalTrials.gov registry entry for NCT03671655 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 4 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 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bare metal stent is the first listed.
NCT03671655 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03671655 about?
NCT03671655 is a clinical study titled "Excellence in Peripheral Arterial Disease Treatment of Superficial Femoral Artery Disease With Drug-eluting Stents". The superficial femoral artery (SFA) is frequently involved in atherosclerosis and is the most common target of lower extremity endovascular procedures performed in patients with claudication. Endovascular treatment of SFA is challenging, given its exceptional predisposition to atherosclerosis and i...
What is the current status of trial NCT03671655?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2014-01. Estimated completion is 2015-08-31.
What interventions are being tested in trial NCT03671655?
The interventions under investigation include: Bare metal stent (DEVICE), Drug-eluting stent (DEVICE).
Who is sponsoring clinical trial NCT03671655?
This trial is sponsored by North Texas Veterans Healthcare System, which has 23 total clinical trials registered on ClinicalTrials.gov.
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