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

NCT05082532 | Unknown

• 1 other identifier: SUPERA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoropopliteal Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients with critical and subcritical femoropopliteal arterial occlusions

EXPERIMENTAL

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) .

Interventions

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

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.

patients with critical and subcritical femoropopliteal arterial occlusions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, +20, Egypt

Location

Related Publications (1)

• 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.

  PMID: 19624075 BACKGROUND

Central Study Contacts

ahmed A hussein, master of vascular surgery

CONTACT

+20-088-0291608774; ahmednaserhussein7@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: October 19, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)