Clinical trial NCT02011984: Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system
Official title: Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system in Peripheral Superficial Femoral Arteries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Artery Disease
Lead sponsor: Eucatech AG
Sponsor class: INDUSTRY
First posted: 2013-12-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with de novo stenotic lesions in the superficial femoral artery

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.

Detailed description: The aim of this non-randomized post-market clinical follow-up study is to confirm 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 superficial femoral artery in 120 compliant patients suitable for stent angioplasty. The primary end point is the target lesion revascularization after 12 months. Further follow-ups are scheduled at discharge, 30 days, 6 and 24 months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.)

Primary outcomes:
measure: Target lesion revascularization (TLR)
timeFrame: 12 months
Secondary outcomes:
measure: Adverse Event
timeFrame: 24 hours
measure: Adverse Event
timeFrame: 48 hours
measure: Adverse Event
timeFrame: 6 months
measure: Adverse Event
timeFrame: 12 months
measure: Adverse Event
timeFrame: 24 months
measure: Technical success
timeFrame: 24 hours
measure: Procedural success
timeFrame: 24 hours
measure: Walking Impairment Questionnaire
timeFrame: 6 months
measure: Walking Impairment Questionnaire
timeFrame: 12 months
measure: Rutherford classification
timeFrame: 48 hours
measure: Rutherford classification
timeFrame: 6 months
measure: Rutherford classification
timeFrame: 12 months
measure: Rutherford classification
timeFrame: 24 months
measure: Health-related quality of life (SF-36 questionnaire)
timeFrame: 12 months
measure: Primary patency
timeFrame: 6 months
measure: Primary patency
timeFrame: 12 months
measure: Primary patency
timeFrame: 24 months
measure: Ankle brachial index (ABI)
timeFrame: 48 hours
measure: Ankle brachial index (ABI)
timeFrame: 6 months
measure: Ankle brachial index (ABI)
timeFrame: 12 months
measure: Ankle brachial index (ABI)
timeFrame: 24 months
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Uniklinikum Freiburg, Abteilung Röntgendiagnostik
state: Baden Württemberg
city: Marburg
country: Germany
facility: Uniklinikum Gießen und Marburg, Diagnostische und Interventionelle Radiologie
state: Hessen
city: Düsseldorf
country: Germany
facility: Augusta-Krankenhaus, Klinik für Gefäßchrirugie
state: Nordrhein - Westfalen
city: Zwickau
country: Germany
facility: Heinrich Braun Klinikum Zwickau, Radiologie und Neuroradiologie
state: Sachsen
city: Pavia
country: Italy
facility: CCP - Istituto di Cura "Città di Pavia"
state: Lombardy
Study officials:
affiliation: Eucatech AG
name: Michael Giese, Phd
role: STUDY_CHAIR
References: