NCT02011984

Brief Summary

Non-randomized multicenter post-market study to confirm the long-term safety and effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in the superficial femoral artery in 100 compliant patients suitable for stent angioplasty. The CE-approved device will be used according to its intended use. Beyond the standard of care no further interventions are scheduled. Therefore, this trial is subject to the exception to the rule §23b of the German Medical Device Act (MPG), which includes the national implementation of EC directive 93/42/EEC.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
2 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

2.2 years

First QC Date

November 15, 2013

Last Update Submit

February 10, 2015

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Target lesion revascularization (TLR)

    Target lesion revascularization (TLR) rate

    12 months

Secondary Outcomes (21)

  • Adverse Event

    24 hours

  • Adverse Event

    48 hours

  • Adverse Event

    6 months

  • Adverse Event

    12 months

  • Adverse Event

    24 months

  • +16 more secondary outcomes

Study Arms (1)

peripheral artery disease

de novo stenotic lesions in superficial femoral artery

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with de novo stenotic lesions in the superficial femoral artery

You may qualify if:

  • Age of 18 to 95 years
  • Male or non-pregnant female
  • De novo lesions\>70% or occlusions in the SFA (Superficial Femoral Artery) arteries suitable for stent angioplasty
  • Max. 1 lesion within each leg should be treated as study lesions
  • Lesions length range from ≥3 cm to ≤18 cm
  • A patent inflow artery free from significant lesions (\>50 % stenosis) as confirmed by angiography. Treatment of target lesion acceptable after successful treatment of inflow artery lesions.
  • Reference vessel diameter ≥3 mm and ≤ 7 mm
  • Successful guide wire passage of the lesion
  • Symptomatic peripheral artery disease (Rutherford stage 2 to 5)
  • Patient is willing to provide informed consent and comply with the required follow-up visits, testing schedule, and medication regimen

You may not qualify if:

  • Patients for whom an anti-platelet therapy, anticoagulants or thrombolytics are contraindicated
  • Patients presenting a lasting intraluminal thrombosis at the lesion after a thrombolytic therapy
  • Perforation at the location of the angioplasty characterized by secretion of the contrast medium
  • Aneurysm of the artery to be treated
  • All common contraindications for a PTA (Percutaneous Transluminal Angioplasty)
  • Contraindications for stent angioplasty
  • Hypersensitivity/allergy to nickel-titanium
  • Hypersensitivity/allergy to any of the components of the delivery \& dilation system
  • Severe renal insufficiency (creatinine\>2.0 mg/dL or glomerular filtration rate \< 60 ml/min/1.73)
  • Uncorrected bleeding disorder
  • Major gastrointestinal bleeding within the last 6 months.
  • Ipsilateral intervention other than target vessel
  • Untreated ipsilateral iliac artery stenosis \>70 %
  • Previous stenting or prior surgery of the SFA
  • In-stent restenosis
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Uniklinikum Freiburg, Abteilung Röntgendiagnostik

Freiburg im Breisgau, Baden-Wurttemberg, 79095, Germany

RECRUITING

Uniklinikum Gießen und Marburg, Diagnostische und Interventionelle Radiologie

Marburg, Hesse, 35043, Germany

RECRUITING

Augusta-Krankenhaus, Klinik für Gefäßchrirugie

Düsseldorf, North Rhine-Westphalia, 40472, Germany

RECRUITING

Heinrich Braun Klinikum Zwickau, Radiologie und Neuroradiologie

Zwickau, Saxony, 08060, Germany

RECRUITING

CCP - Istituto di Cura "Città di Pavia"

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Michael Giese, Phd

    Eucatech AG

    STUDY CHAIR

Central Study Contacts

Claudia Marx, MD

CONTACT

00497621167333c.marx@clinical-evaluation.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2013

First Posted

December 16, 2013

Study Start

December 1, 2013

Primary Completion

March 1, 2016

Study Completion

February 1, 2017

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

DE(4)IT(1)