Excellence in Peripheral Arterial Disease Treatment of Superficial Femoral Artery Disease With Drug-eluting Stents
Public ClinicalTrials.gov record NCT03671655. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Excellence in Peripheral Arterial Disease Treatment of Superficial Femoral Artery Disease With Drug-eluting Stents (XL PAD SFA DES)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 evidence.Thus, the purpose of this study is to conduct a randomized pilot trial comparing DES and BMS for percutaneous revascularization of SFA.
Study identification
- NCT ID
- NCT03671655
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 4 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2013
- Primary completion
- Aug 30, 2015
- Completion
- Aug 30, 2015
- Last update posted
- Sep 13, 2018
2014 – 2015
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Texas Veterans Affairs Health Care System | Dallas | Texas | 75216 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03671655, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 13, 2018 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03671655 live on ClinicalTrials.gov.