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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoropopliteal Occlusive Disease
• Intervention / Treatment: Other: Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ahmed A hussein, master of vascular surgery; Phone Number: +20-088-0291608774; Email: ahmednaserhussein7@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, +20
    • Assiut University
    • Contact: ahmed A hussein; Email: ahmednaserhussein7@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: patients with critical and subcritical femoropopliteal arterial occlusions; 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.

Other: Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2025
• Study Completion (ANTICIPATED): September 1, 2025

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (ACTUAL): October 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: SUPERA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No