Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system
NCT ID: NCT02011984
Last Updated: 2015-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2013-12-31
2017-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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peripheral artery disease
de novo stenotic lesions in superficial femoral artery
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Acute myocardial infarct within 72 h
* Less than one patent crural artery
* Popliteal stenosis \> 70 %
* Manifest hyperthyroidism
* Acute onset of symptoms
* Leg-threatening ischemia
* Multimorbid patient with poor general condition
* Pregnant woman or becoming pregnant in \< 2 yrs
* Living more than 100 km apart from the study center
* Patient actively participating in another investigational device or drug study
* History of hemorrhagic stroke within 3 months
* Previous or planned surgical or interventional procedure within 30 days of the procedure
* Acute or sub-acute thrombus in target vessel
* Acute vessel occlusion or sudden symptom onset
* Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery
* Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.)
18 Years
95 Years
ALL
No
Sponsors
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Eucatech AG
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Giese, Phd
Role: STUDY_CHAIR
Eucatech AG
Locations
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Uniklinikum Freiburg, Abteilung Röntgendiagnostik
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Uniklinikum Gießen und Marburg, Diagnostische und Interventionelle Radiologie
Marburg, Hesse, Germany
Augusta-Krankenhaus, Klinik für Gefäßchrirugie
Düsseldorf, North Rhine-Westphalia, Germany
Heinrich Braun Klinikum Zwickau, Radiologie und Neuroradiologie
Zwickau, Saxony, Germany
CCP - Istituto di Cura "Città di Pavia"
Pavia, Lombardy, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ECT024ResiCSfaRegV10
Identifier Type: OTHER
Identifier Source: secondary_id
recam2013_eucatech
Identifier Type: -
Identifier Source: org_study_id
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