search
Back to results

Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases

Primary Purpose

Femoropopliteal Occlusive Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoropopliteal Occlusive Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Patients with critical limb ischemia(grade 4,5&6 Rutherford classification) and patients with disabling claudications which interferes with routine activities (grade 3 Rutherford classification).
  • Patients with chronic total occlusion(CTO) of femoropopliteal segment which is equal or beyond 10 centimeters length.
  • Patients with recoil after transluminal angioplasty or occlusion in previously deployed stent.
  • If the lesion extends to popliteal artey against knee flexion.

Exclusion criteria:

  • Pediatric patients.
  • Patients with isolated infra-popliteal occlusion.
  • Patients with popliteal blind segment with bad runoff.
  • Patients with acute thrombotic occlusions.
  • Patients with previous bypass surgery in affected limb.
  • Patients with aneurysmal lesion in the affected limb.

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with critical and subcritical femoropopliteal arterial occlusions

Arm Description

patients presented with chronic ischemia in rest pain stage or ulcerative and gangrenous toes and by investigations long chronic total occlusion of femoropopliteal segment was documented may need stenting of the diseased segment especially if the lesion recoils after previous angioplasty. Nitinol interwoven stent has a unique design that achieves adherence to vessel wall and also malleability with the vessel and surrounding muscle motion so investigators predict more extended patency time with this interventional option and want to investigate this prediction using a scientific experimental pathway.

Outcomes

Primary Outcome Measures

peak systolic velocity in centimeters per second (cm/sec) through the deployed stent in serial duplex imaging
Crossing the lesion and deploying the stent without residual stenosis or degree of stenosis is less than 30% and assess the time the stent remains patent without re interventions. the outcome will be measured on clinical aspect and imaging aspect. Clinically ,investigators will trace the ankle brachial index (ankle systolic pressure relative to systemic systolic pressure), wound healing progress through cascade measuring of ulcer diameter in centimeters till complete healing and pain improvement depending on visual analogue score from 0 to 10.Imaging follow up, investigators will trace diseased segment diameters after intervention in millimeters and peak systolic velocity through the stent in centimeters per second.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2021
Last Updated
October 5, 2021
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT05082532
Brief Title
Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
Official Title
Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass.
Detailed Description
Stenting of the femoro-popliteal segment is indicated in case of elastic recoil, flow-limiting dissection, insufficient per- cutaneous transluminal angioplasty (PTA) or long lesion length. However, in-stent restenosis (ISR) or fracture after endovascular treatment remains a serious concern, especially for lesions of a long segment or near the knee joint. Besides the current availability of covered or drug-coated stents, there is the self-expandable bare-metal Nitinol stent which rapidly evolved during the last decade from closed-cell to open-cell and, more recently, to interwoven stents. interwoven nitinol stent design of fully connected structures facilitates a continuous but a traumatic synergy between the stent and vessel wall and hence enables axial compliance. Investigators here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropopliteal complex occlusive lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoropopliteal Occlusive Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with critical and subcritical femoropopliteal arterial occlusions
Arm Type
Experimental
Arm Description
patients presented with chronic ischemia in rest pain stage or ulcerative and gangrenous toes and by investigations long chronic total occlusion of femoropopliteal segment was documented may need stenting of the diseased segment especially if the lesion recoils after previous angioplasty. Nitinol interwoven stent has a unique design that achieves adherence to vessel wall and also malleability with the vessel and surrounding muscle motion so investigators predict more extended patency time with this interventional option and want to investigate this prediction using a scientific experimental pathway.
Intervention Type
Other
Intervention Name(s)
Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .
Intervention Description
we here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropoliteal complex occlusive lesions.
Primary Outcome Measure Information:
Title
peak systolic velocity in centimeters per second (cm/sec) through the deployed stent in serial duplex imaging
Description
Crossing the lesion and deploying the stent without residual stenosis or degree of stenosis is less than 30% and assess the time the stent remains patent without re interventions. the outcome will be measured on clinical aspect and imaging aspect. Clinically ,investigators will trace the ankle brachial index (ankle systolic pressure relative to systemic systolic pressure), wound healing progress through cascade measuring of ulcer diameter in centimeters till complete healing and pain improvement depending on visual analogue score from 0 to 10.Imaging follow up, investigators will trace diseased segment diameters after intervention in millimeters and peak systolic velocity through the stent in centimeters per second.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with critical limb ischemia(grade 4,5&6 Rutherford classification) and patients with disabling claudications which interferes with routine activities (grade 3 Rutherford classification). Patients with chronic total occlusion(CTO) of femoropopliteal segment which is equal or beyond 10 centimeters length. Patients with recoil after transluminal angioplasty or occlusion in previously deployed stent. If the lesion extends to popliteal artey against knee flexion. Exclusion criteria: Pediatric patients. Patients with isolated infra-popliteal occlusion. Patients with popliteal blind segment with bad runoff. Patients with acute thrombotic occlusions. Patients with previous bypass surgery in affected limb. Patients with aneurysmal lesion in the affected limb.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed A hussein, master of vascular surgery
Phone
+20-088-0291608774
Email
ahmednaserhussein7@yahoo.com
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
+20
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed A hussein
Email
ahmednaserhussein7@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19624075
Citation
Mewissen MW. Primary nitinol stenting for femoropopliteal disease. J Endovasc Ther. 2009 Apr;16(2 Suppl 2):II63-81. doi: 10.1583/08-2658.1.
Results Reference
background

Learn more about this trial

Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases

We'll reach out to this number within 24 hrs