Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system (RECAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Eucatech AG
Sponsor:
Information provided by (Responsible Party):
Eucatech AG
ClinicalTrials.gov Identifier:
NCT02011984
First received: November 15, 2013
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition
Peripheral Artery Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system in Peripheral Superficial Femoral Arteries

Resource links provided by NLM:


Further study details as provided by Eucatech AG:

Primary Outcome Measures:
  • Target lesion revascularization (TLR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Target lesion revascularization (TLR) rate


Secondary Outcome Measures:
  • Adverse Event [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Adverse Event rate

  • Adverse Event [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Adverse Event rate

  • Adverse Event [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Adverse Event rate

  • Adverse Event [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse Event rate

  • Adverse Event [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Adverse Event rate

  • Technical success [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The ability to successfully complete stent angioplasty and achieve a residual diameter stenosis of ≤ 30 %.

  • Procedural success [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Procedural success rate

  • Walking Impairment Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in Walking Impairment Questionnaire scores

  • Walking Impairment Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in Walking Impairment Questionnaire scores

  • Rutherford classification [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Change from baseline in Rutherford stage

  • Rutherford classification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in Rutherford stage

  • Rutherford classification [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in Rutherford stage

  • Rutherford classification [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline in Rutherford stage

  • Health-related quality of life (SF-36 questionnaire) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in health-related quality of life (SF-36 questionnaire scores)

  • Primary patency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)

  • Primary patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)

  • Primary patency [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)

  • Ankle brachial index (ABI) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Change from baseline in Ankle brachial index (ABI)

  • Ankle brachial index (ABI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in Ankle brachial index (ABI)

  • Ankle brachial index (ABI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in Ankle brachial index (ABI)

  • Ankle brachial index (ABI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline in Ankle brachial index (ABI)


Estimated Enrollment: 120
Study Start Date: December 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
peripheral artery disease
de novo stenotic lesions in superficial femoral artery

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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with de novo stenotic lesions in the superficial femoral artery

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011984

Contacts
Contact: Claudia Marx, MD 00497621167333 ext 20 c.marx@clinical-evaluation.com

Locations
Germany
Uniklinikum Freiburg, Abteilung Röntgendiagnostik Recruiting
Freiburg, Baden Württemberg, Germany, 79095
Contact: Wulf Euringer, M.D.    0049 761 270 ext 38580    wulf.euringer@uniklinik-freiburg.de   
Principal Investigator: Wulf Euringer, M.D.         
Uniklinikum Gießen und Marburg, Diagnostische und Interventionelle Radiologie Recruiting
Marburg, Hessen, Germany, 35043
Contact: Mykhaylo Burbelko, M.D.    0049 6421 58 ext 65912    burbelko@med.uni-marburg.de   
Principal Investigator: Mykhaylo Burbelko, M.D.         
Augusta-Krankenhaus, Klinik für Gefäßchrirugie Recruiting
Düsseldorf, Nordrhein - Westfalen, Germany, 40472
Contact: Ralf Kolvenbach, Prof.    0049 211 9043 ext 301    kolvenbach@vkkd-kliniken.de   
Principal Investigator: Ralf Kolvenbach, Prof.         
Heinrich Braun Klinikum Zwickau, Radiologie und Neuroradiologie Recruiting
Zwickau, Sachsen, Germany, 08060
Contact: Jörg Thalwitzer, M.D.    0049 375 ext -4854/-4855    irad@hbk-zwickau.de   
Principal Investigator: Jörg Thalwitzer, M.D.         
Italy
CCP - Istituto di Cura "Città di Pavia" Recruiting
Pavia, Lombardy, Italy, 27100
Contact: Cesare Massa Saluzzo, M.D.    0039 3349419996    segreteria@centroendovascolare.it   
Principal Investigator: Cesare Massa Saluzzo, M.D.         
Sponsors and Collaborators
Eucatech AG
Investigators
Study Chair: Michael Giese, Phd Eucatech AG
  More Information

No publications provided

Responsible Party: Eucatech AG
ClinicalTrials.gov Identifier: NCT02011984     History of Changes
Other Study ID Numbers: recam2013_eucatech, ECT024ResiCSfaRegV10
Study First Received: November 15, 2013
Last Updated: February 14, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014