- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02011984
Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system (RECAM)
Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system in Peripheral Superficial Femoral Arteries
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Claudia Marx, MD
- Numero di telefono: 20 00497621167333
- Email: c.marx@clinical-evaluation.com
Luoghi di studio
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Baden Württemberg
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Freiburg, Baden Württemberg, Germania, 79095
- Reclutamento
- Uniklinikum Freiburg, Abteilung Röntgendiagnostik
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Contatto:
- Wulf Euringer, M.D.
- Numero di telefono: 38580 0049 761 270
- Email: wulf.euringer@uniklinik-freiburg.de
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Investigatore principale:
- Wulf Euringer, M.D.
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Hessen
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Marburg, Hessen, Germania, 35043
- Reclutamento
- Uniklinikum Gießen und Marburg, Diagnostische und Interventionelle Radiologie
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Contatto:
- Mykhaylo Burbelko, M.D.
- Numero di telefono: 65912 0049 6421 58
- Email: burbelko@med.uni-marburg.de
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Investigatore principale:
- Mykhaylo Burbelko, M.D.
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Nordrhein - Westfalen
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Düsseldorf, Nordrhein - Westfalen, Germania, 40472
- Reclutamento
- Augusta-Krankenhaus, Klinik für Gefäßchrirugie
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Contatto:
- Ralf Kolvenbach, Prof.
- Numero di telefono: 301 0049 211 9043
- Email: kolvenbach@vkkd-kliniken.de
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Investigatore principale:
- Ralf Kolvenbach, Prof.
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Sachsen
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Zwickau, Sachsen, Germania, 08060
- Reclutamento
- Heinrich Braun Klinikum Zwickau, Radiologie und Neuroradiologie
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Contatto:
- Jörg Thalwitzer, M.D.
- Numero di telefono: -4854/-4855 0049 375
- Email: irad@hbk-zwickau.de
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Investigatore principale:
- Jörg Thalwitzer, M.D.
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Lombardy
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Pavia, Lombardy, Italia, 27100
- Reclutamento
- CCP - Istituto di Cura "Città di Pavia"
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Contatto:
- Cesare Massa Saluzzo, M.D.
- Numero di telefono: 0039 3349419996
- Email: segreteria@centroendovascolare.it
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Investigatore principale:
- Cesare Massa Saluzzo, M.D.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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peripheral artery disease
de novo stenotic lesions in superficial femoral artery
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Target lesion revascularization (TLR)
Lasso di tempo: 12 months
|
Target lesion revascularization (TLR) rate
|
12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Adverse Event
Lasso di tempo: 24 hours
|
Adverse Event rate
|
24 hours
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Adverse Event
Lasso di tempo: 48 hours
|
Adverse Event rate
|
48 hours
|
Adverse Event
Lasso di tempo: 6 months
|
Adverse Event rate
|
6 months
|
Adverse Event
Lasso di tempo: 12 months
|
Adverse Event rate
|
12 months
|
Adverse Event
Lasso di tempo: 24 months
|
Adverse Event rate
|
24 months
|
Technical success
Lasso di tempo: 24 hours
|
The ability to successfully complete stent angioplasty and achieve a residual diameter stenosis of ≤ 30 %.
|
24 hours
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Procedural success
Lasso di tempo: 24 hours
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Procedural success rate
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24 hours
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Walking Impairment Questionnaire
Lasso di tempo: 6 months
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Change from baseline in Walking Impairment Questionnaire scores
|
6 months
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Walking Impairment Questionnaire
Lasso di tempo: 12 months
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Change from baseline in Walking Impairment Questionnaire scores
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12 months
|
Rutherford classification
Lasso di tempo: 48 hours
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Change from baseline in Rutherford stage
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48 hours
|
Rutherford classification
Lasso di tempo: 6 months
|
Change from baseline in Rutherford stage
|
6 months
|
Rutherford classification
Lasso di tempo: 12 months
|
Change from baseline in Rutherford stage
|
12 months
|
Rutherford classification
Lasso di tempo: 24 months
|
Change from baseline in Rutherford stage
|
24 months
|
Health-related quality of life (SF-36 questionnaire)
Lasso di tempo: 12 months
|
Change from baseline in health-related quality of life (SF-36 questionnaire scores)
|
12 months
|
Primary patency
Lasso di tempo: 6 months
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Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)
|
6 months
|
Primary patency
Lasso di tempo: 12 months
|
Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)
|
12 months
|
Primary patency
Lasso di tempo: 24 months
|
Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)
|
24 months
|
Ankle brachial index (ABI)
Lasso di tempo: 48 hours
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Change from baseline in Ankle brachial index (ABI)
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48 hours
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Ankle brachial index (ABI)
Lasso di tempo: 6 months
|
Change from baseline in Ankle brachial index (ABI)
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6 months
|
Ankle brachial index (ABI)
Lasso di tempo: 12 months
|
Change from baseline in Ankle brachial index (ABI)
|
12 months
|
Ankle brachial index (ABI)
Lasso di tempo: 24 months
|
Change from baseline in Ankle brachial index (ABI)
|
24 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Michael Giese, Phd, Eucatech AG
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- recam2013_eucatech
- ECT024ResiCSfaRegV10 (Altro identificatore: CERES)
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