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COMPLETED NA

EverFlex Post Approval Study

NCT01680835 · View on ClinicalTrials.gov ↗

Study Summary

This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.

Interventions

  • DEVICE EverFlex™ Self-Expanding Peripheral Stent System

Study Locations (20)

Pennsylvania

  • Lankenau Institute for Medical Research — Bryn Mawr
  • Thomas Jefferson University — Philadelphia
  • Allegheny General Hospital — Pittsburgh

California

  • Memorial Medical Center — Modesto
  • Sutter Memorial Hospital — Sacramento

Illinois

  • DuPage Medical Group — Downers Grove
  • Rockford Cardiovascular Associates — Rockford

South Dakota

  • Black Hills Cardiovascular Research — Rapid City
  • Sanford Research — Sioux Falls

Arizona

  • St. Luke's Medical Center — Phoenix

Delaware

  • Christiana Care Health Services — Newark

Florida

  • First Coast Cardiovascular Institute, P.A. — Jacksonville

Georgia

  • Augusta Vascular Center — Augusta

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2013-01-14
Est. Completion 2019-02-04
Phase NA

Sponsor

Medtronic Endovascular

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01680835

The ClinicalTrials.gov registry entry for NCT01680835 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 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Endovascular, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 1 intervention — of which EverFlex™ Self-Expanding Peripheral Stent System 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: NCT01680835 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Pennsylvania, California, Illinois. 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 NCT01680835 about?

NCT01680835 is a clinical study titled "EverFlex Post Approval Study". This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.

What is the current status of trial NCT01680835?

This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2013-01-14. Estimated completion is 2019-02-04.

What conditions does trial NCT01680835 study?

This clinical trial studies the following conditions: Peripheral Arterial Disease, Lower Extremity Arterial 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 NCT01680835?

The interventions under investigation include: EverFlex™ Self-Expanding Peripheral Stent System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01680835?

This trial is sponsored by Medtronic Endovascular, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01680835 being conducted?

This trial has 20 study locations across Arizona, California, Delaware, Florida, Georgia. 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