Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system

Peripheral Artery Disease Clinical Trial

— RECAM  

Official title:

Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system in Peripheral Superficial Femoral Arteries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02011984
• Other study ID #: recam2013_eucatech
• Secondary ID: ECT024ResiCSfaRe
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2013
• Last updated: February 10, 2015
• Start date: December 2013
• Est. completion date: February 2017

Study information

• Verified date: February 2015
• Source: Eucatech AG
• Contact: Claudia Marx, MD
• Phone: 00497621167333
• Email: c.marx[@]clinical-evaluation.com
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
Germany	Augusta-Krankenhaus, Klinik für Gefäßchrirugie	Düsseldorf	Nordrhein - Westfalen
Germany	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
Italy	CCP - Istituto di Cura "Città di Pavia"	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
Eucatech AG

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion revascularization (TLR)	Target lesion revascularization (TLR) rate	12 months	Yes
Secondary	Adverse Event	Adverse Event rate	24 hours	Yes
Secondary	Adverse Event	Adverse Event rate	48 hours	Yes
Secondary	Adverse Event	Adverse Event rate	6 months	Yes
Secondary	Adverse Event	Adverse Event rate	12 months	Yes
Secondary	Adverse Event	Adverse Event rate	24 months	Yes
Secondary	Technical success	The ability to successfully complete stent angioplasty and achieve a residual diameter stenosis of = 30 %.	24 hours	No
Secondary	Procedural success	Procedural success rate	24 hours	No
Secondary	Walking Impairment Questionnaire	Change from baseline in Walking Impairment Questionnaire scores	6 months	No
Secondary	Walking Impairment Questionnaire	Change from baseline in Walking Impairment Questionnaire scores	12 months	No
Secondary	Rutherford classification	Change from baseline in Rutherford stage	48 hours	No
Secondary	Rutherford classification	Change from baseline in Rutherford stage	6 months	No
Secondary	Rutherford classification	Change from baseline in Rutherford stage	12 months	No
Secondary	Rutherford classification	Change from baseline in Rutherford stage	24 months	No
Secondary	Health-related quality of life (SF-36 questionnaire)	Change from baseline in health-related quality of life (SF-36 questionnaire scores)	12 months	No
Secondary	Primary patency	Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)	6 months	No
Secondary	Primary patency	Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)	12 months	No
Secondary	Primary patency	Percentage of lesions that reach endpoint without TLR or with stenosis < 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) < 2.4)	24 months	No
Secondary	Ankle brachial index (ABI)	Change from baseline in Ankle brachial index (ABI)	48 hours	No
Secondary	Ankle brachial index (ABI)	Change from baseline in Ankle brachial index (ABI)	6 months	No
Secondary	Ankle brachial index (ABI)	Change from baseline in Ankle brachial index (ABI)	12 months	No
Secondary	Ankle brachial index (ABI)	Change from baseline in Ankle brachial index (ABI)	24 months	No