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a Physician-inititated Trial Investigating the iVolution Nitinol Stent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02430922
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program

Brief Summary:
The objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: iVolution nitinol stent Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EVOLUTION STUDY, a Physician-inititated Trial Investigating the Efficacy of the Self-Expanding iVolution Nitinol Stent for Treatment of Femoropopliteal Lesions
Actual Study Start Date : April 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: iVolution stent
Patient's treated with the iVolution stent from iVascular for the treatment of femoropopliteal lesions.
Device: iVolution nitinol stent



Primary Outcome Measures :
  1. Primary Patency at 12 months [ Time Frame: 12 months ]
    freedom from >50% restenosis at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention


Secondary Outcome Measures :
  1. Technical Success [ Time Frame: Procedure ]
  2. Primary Patency at 1 & 6 months [ Time Frame: 1 & 6 months ]
  3. Freedom from Target Lesion Revascularization (TLR) at 1, 6 and 12 months [ Time Frame: at all follow-up visits ]
  4. Clinical Success at 1, 6 and 12 months [ Time Frame: at all follow-up visits ]
    Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-, 6- & 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.

  5. Serious adverse events until follow-up completions [ Time Frame: 1,6,12 months and interem visits ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. De novo lesion located in the femoropopliteal arteries suitable for endovascular treatment
  2. Patient presenting with a score from 2 to 4 according to the Rutherford classification
  3. Patient is willing and able to comply with specified follow-up evaluations at the predefined time intervals
  4. Patient is >18 years old
  5. Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
  6. Prior to enrollment, the target lesion was crossed with standard guidewire manipulation One target lesion is located within the native SFA: distal point 3 cm above knee joint
  7. The target lesion has angiographic evidence of stenosis or occlusion
  8. Length of the target lesion is ≤ 15 cm by visual estimation
  9. Target vessel diameter visually estimated is ≥4 mm and ≤7 mm
  10. There is angiographic evidence of at least one vessel-runoff to the foot

Exclusion Criteria:

  1. Presence of a stent in the target vessel that was placed during a previous procedure
  2. Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
  3. Previous bypass surgery in the same limb
  4. Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
  5. Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
  6. Perforation at the angioplasty site evidenced by extravasation of contrast medium
  7. Patients with known hypersensitivity to nickel-titanium or other study device components
  8. Patients with uncorrected bleeding disorders
  9. Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
  10. Life expectancy of less than 12 months
  11. Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
  12. Use of thrombectomy, atherectomy or laser devices during procedure
  13. Any patient considered to be hemodynamically unstable at onset of procedure
  14. Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430922


Locations
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Belgium
Imelda Hospital
Bonheiden, Antwerp, Belgium, 2820
A.Z. Sint-Blasius
Dendermonde, East-Flanders, Belgium, 9200
Heilig-Hart Ziekenhuis
Tienen, Flemish Brabant, Belgium, 3300
OLV Aalst
Aalst, Oost-Vlaanderen, Belgium, 9300
Sponsors and Collaborators
Flanders Medical Research Program
Investigators
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Principal Investigator: Marc Bosiers, MD Flanders Medical Research Program
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Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT02430922    
Other Study ID Numbers: FMRP-150106
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases