Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions (DUR-POP)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
nitinol stent
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring symptomatic popliteal artery stenosis or occlusion
Eligibility Criteria
Inclusion Criteria:
General Inclusion criteria
- De novo, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement
- Patient presenting a score from 2 to 5 following Rutherford classification
- Patient is willing to comply with specified follow-up evaluations at the specified times
- Patient is >18 years old
- Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Prior to enrollment, the guidewire has crossed target lesion
- Patient is eligible for treatment with the self-expanding nitinol EverFlex (ev3) stent
Angiographic Inclusion Criteria
- The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
- The target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type A or B lesions according the TASC II guidelines
- Target vessel diameter visually estimated is >3.5mm and <7.5 mm
- There is angiographic evidence of at least one-vessel-runoff to the foot
Exclusion Criteria:
- Presence of another stent in the target vessel that was placed during a previous procedure
- Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
- Previous by-pass surgery in the same limb
- Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
- Perforation at the angioplasty site evidenced by extravasation of contrast medium
- Patients with known hypersensitivity to nickel-titanium
- Patients with uncorrected bleeding disorders
- Aneurysm located at the level of the SFA and/or popliteal artery
- Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- Life expectancy of less than twelve months
- Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis > 30% or ipsilateral iliac treatment conducted after the target lesion procedure
- Use of thrombectomy, artherectomy or laser devices during procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
Sites / Locations
- Imeldaziekenhuis
- University Hospital Antwerp
- A.Z. Sint-Blasius
- Heilig-Hart Ziekenhuis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nitinol stent
Arm Description
Protégé EverFlex stent
Outcomes
Primary Outcome Measures
primary patency
primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR within 12 months
Secondary Outcome Measures
Technical success
Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging
Primary patency rate at 6-, 12-month follow-up.
Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent.
Clinical success
Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
tent fracture rate at 12-month follow-up
Determined according the following classification on x-ray: Class 0 (no strut factures); Class I (single tine fracture); Class II (multiple tine factures); Class III (Stent fracture(s) with preserved alignment of the components); Class IV (Stent fracture(s) with mal-alignment of the components); Class V (Stent fracture(s) in a trans-axial spiral configuration)
Serious adverse events
Defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Full Information
NCT ID
NCT01412450
First Posted
July 2, 2010
Last Updated
September 30, 2013
Sponsor
Flanders Medical Research Program
1. Study Identification
Unique Protocol Identification Number
NCT01412450
Brief Title
Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions
Acronym
DUR-POP
Official Title
DURABILITY-POP Study - Physician Initiated Trial Investigating the Efficacy of the Implant of Protégé EverFlex Nitinol Stents in Popliteal Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flanders Medical Research Program
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
symptomatic popliteal artery stenosis or occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nitinol stent
Arm Type
Experimental
Arm Description
Protégé EverFlex stent
Intervention Type
Device
Intervention Name(s)
nitinol stent
Other Intervention Name(s)
Protégé EverFlex stent
Intervention Description
implantation of one Protégé EverFlex stent
Primary Outcome Measure Information:
Title
primary patency
Description
primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR within 12 months
Time Frame
12 months post-procedure
Secondary Outcome Measure Information:
Title
Technical success
Description
Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging
Time Frame
1 day post-procedure
Title
Primary patency rate at 6-, 12-month follow-up.
Description
Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent.
Time Frame
6-, 12-month follow-up
Title
Clinical success
Description
Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Time Frame
6-, 12-month follow-up
Title
tent fracture rate at 12-month follow-up
Description
Determined according the following classification on x-ray: Class 0 (no strut factures); Class I (single tine fracture); Class II (multiple tine factures); Class III (Stent fracture(s) with preserved alignment of the components); Class IV (Stent fracture(s) with mal-alignment of the components); Class V (Stent fracture(s) in a trans-axial spiral configuration)
Time Frame
12-month follow-up
Title
Serious adverse events
Description
Defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
General Inclusion criteria
De novo, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement
Patient presenting a score from 2 to 5 following Rutherford classification
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient is >18 years old
Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Prior to enrollment, the guidewire has crossed target lesion
Patient is eligible for treatment with the self-expanding nitinol EverFlex (ev3) stent
Angiographic Inclusion Criteria
The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
The target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type A or B lesions according the TASC II guidelines
Target vessel diameter visually estimated is >3.5mm and <7.5 mm
There is angiographic evidence of at least one-vessel-runoff to the foot
Exclusion Criteria:
Presence of another stent in the target vessel that was placed during a previous procedure
Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
Previous by-pass surgery in the same limb
Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
Perforation at the angioplasty site evidenced by extravasation of contrast medium
Patients with known hypersensitivity to nickel-titanium
Patients with uncorrected bleeding disorders
Aneurysm located at the level of the SFA and/or popliteal artery
Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
Life expectancy of less than twelve months
Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis > 30% or ipsilateral iliac treatment conducted after the target lesion procedure
Use of thrombectomy, artherectomy or laser devices during procedure
Any patient considered to be hemodynamically unstable at onset of procedure
Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Bosiers, MD
Organizational Affiliation
A.Z. Sint-Blasius
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imeldaziekenhuis
City
Bonheiden
State/Province
Antwerp
ZIP/Postal Code
2820
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
A.Z. Sint-Blasius
City
Dendermonde
State/Province
East-Flanders
ZIP/Postal Code
9200
Country
Belgium
Facility Name
Heilig-Hart Ziekenhuis
City
Tienen
State/Province
Flemish Brabant
ZIP/Postal Code
3300
Country
Belgium
12. IPD Sharing Statement
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Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions
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