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

Femoropopliteal Occlusive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05082532
• Other study ID #: SUPERA
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: September 2025

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: ahmed A hussein, master of vascular surgery
• Phone: +20-088-0291608774
• Email: ahmednaserhussein7[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Femoropopliteal Occlusive Disease

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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