Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system

• Conditions: Peripheral Artery Disease

• Registration Number: NCT02011984
• Lead Sponsor: Eucatech AG

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.

Study Timeline

• Study First Submitted: 2013-11-15
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-16
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-11
• Primary Completion: 2016-03
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion revascularization (TLR)	12 months	Target lesion revascularization (TLR) rate

Secondary Outcome Measures

Name	Time	Method
Technical success	24 hours	The ability to successfully complete stent angioplasty and achieve a residual diameter stenosis of ≤ 30 %.
Health-related quality of life (SF-36 questionnaire)	12 months	Change from baseline in health-related quality of life (SF-36 questionnaire scores)
Procedural success	24 hours	Procedural success rate
Primary patency	24 months	Percentage of lesions that reach endpoint without TLR or with stenosis \< 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) \< 2.4)
Adverse Event	24 months	Adverse Event rate
Walking Impairment Questionnaire	12 months	Change from baseline in Walking Impairment Questionnaire scores
Rutherford classification	24 months	Change from baseline in Rutherford stage
Ankle brachial index (ABI)	24 months	Change from baseline in Ankle brachial index (ABI)

Trial Locations

Locations (5)

Uniklinikum Freiburg, Abteilung Röntgendiagnostik; 🇩🇪 Freiburg, Baden Württemberg, Germany

Uniklinikum Gießen und Marburg, Diagnostische und Interventionelle Radiologie; 🇩🇪 Marburg, Hessen, Germany

Heinrich Braun Klinikum Zwickau, Radiologie und Neuroradiologie; 🇩🇪 Zwickau, Sachsen, Germany

Augusta-Krankenhaus, Klinik für Gefäßchrirugie; 🇩🇪 Düsseldorf, Nordrhein - Westfalen, Germany

CCP - Istituto di Cura "Città di Pavia"; 🇮🇹 Pavia, Lombardy, Italy