A Study Evaluating the Endovascular Treatment of Subjects with Stenotic or Restenotic Lesions of the Common Femoral Artery with the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy

NCT04349657 | Recruiting DMC

• 1 other identifier: SUPERSURG RCT-v1.0-05MAR2020
• Study Type: interventional
• Target: 286
• Locations: 3 countries
• Sites: 13

Brief Summary

The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery (CFA) of patients presenting with Rutherford classification 2,3 or 4 with a Supera Vascular Mimetic Implant of Abbott, compared to classic surgical common femoral artery endarterectomy. The Supera Vascular Mimetic Implant has an interwoven design and has a high crush resistance and is, when correctly implanted, an ideal stent to treat eccentric calcified plaques in the CFA. An expected total of 143 patients will be treated with the Vascular Mimetic Implant of Abbott and compared to a control group of another 143 patients that will be treated with classic surgical endarterectomy of the common femoral artery. Assignment to the treatment groups will be at random. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months post-procedure. The primary efficacy endpoint is defined as follows: freedom from clinically-driven target lesion revascularization and binary restenosis at 12 months. The primary safety endpoint is defined as follows: a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularisation and wound related complications through 30 days post-index procedure. The secondary endpoints are defined as technical success, primary patency in the deep femoral artery, primary patency in the target lesion, target lesion revascularisation, target vessel revascularisation, binary restenosis, duration of initial hospital stay, sustained clinical improvement, change of walking impairment questionnaire score from baseline, change in target limb Rutherford classification, change in target limb ABI/TBI from baseline, all cause death, thrombosis at the target lesion through 6, 12, 24 and 36 months post-procedure.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Primary efficacy endpoint at 12 months: Primary patency

  To demonstrate the non-inferior efficacy in the group treated with the Supera stent compared to the group treated with endarterectomy for the treatment of atherosclerosis in the common femoral artery (CFA). Efficacy is defined as primary patency: freedom from restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by an independent DUS core lab in CFA without a previous target lesion revascularization through 12 months post-index procedure.

  12 months post-index-procedure

• Primary safety endpoint at 30 days post-index procedure

  To demonstrate superior safety in the group treated with the Supera stent compared to the endarterectomy group for the treatment of atherosclerosis in the CFA. Safety is defined as a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularization (TLR) and wound-related complications (haematoma, seroma, lymphocele, lymphatic leaks with lymphatic fistula, surgical site infections (SSIs) (Szilagyi grade I, II and III)).

  30 days post-index-procedure

Secondary Outcomes (13)

• Technical success: post-procedure residual stenosis <30%

  Index procedure

• Primary patency in the deep femoral artery (DFA), post-index procedure and at 6-, 12-, 24- and 36-months post-index procedure

  6, 12, 24 and 36 months post-index-procedure

• Primary patency at 6, 24 and 36 months

  6, 24 and 36 months post-index-procedure

• TLR at 6-, 12-, 24- and 36-months post-index procedure

  6, 12, 24 and 36 months post-index-procedure

• TVR at 6-, 12-, 24- and 36-months post-index procedure

  6, 12, 24 and 36 months post-index-procedure

Study Arms (2)

Supera Peripheral Stent System treatment group

EXPERIMENTAL

These patients will be treated endovascularly with the Supera Peripheral Stent System (Abbott).

Device: Supera Peripheral Stent System treatment group

Endarterectomy treatment group

ACTIVE COMPARATOR

These patients will be treated surgically with endarterectomy

Procedure: Endarterectomy treatment group

Interventions

Supera Peripheral Stent System treatment group DEVICE

Percutaneous endovascular stenting with the Supera Peripheral Stent System

Supera Peripheral Stent System treatment group

Endarterectomy treatment group PROCEDURE

Surgical treatment through endarterectomy

Endarterectomy treatment group

Eligibility Criteria

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

You may qualify if:

• Patient is ≥18 years old
• Patient presenting a score from 2 to 4 following Rutherford classification
• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient has a life expectancy of at least 12 months
• Prior to enrolment, the guidewire has crossed the target lesion in the endovascular arm. In the surgical arm, the endarterectomy needs to be performed with primary suture or patch implantation
• De novo stenotic or restenotic (post-PTA) lesions (\<100%) located in the common femoral artery, suitable for both endovascular therapy and endarterectomy
• Target lesion is located within the native CFA: localized between 1cm proximal to the origin of the circumflex iliac artery and the proximal (2cm) superficial femoral artery and deep femoral artery (2cm) (Azéma type 2 and 3 lesions)
• There is angiographic evidence of a patent deep femoral artery and/or superficial femoral artery
• The target lesion has angiographic evidence of \>50% stenosis. Occlusions are not allowed.

You may not qualify if:

• Presence of another stent in the target vessel that was placed during a previous procedure
• Previous open surgery in the ipsilateral groin
• Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
• Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
• Patients with known hypersensitivity to nickel-titanium and heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
• Known allergy to contrast media that cannot be adequately pre-medicated prior to study procedure
• Patients with uncorrected bleeding disorders
• Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Ipsilateral inflow (aorto-iliac) artery treatment before target lesion treatment with a residual stenosis \>30%
• Use of thrombectomy, atherectomy or laser device during procedure
• Any patient considered to be hemodynamically unstable at onset of procedure
• Severe medical comorbidities (untreated coronary artery disease/congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would prelude compliance with the study protocol or 1-year life expectancy
• Major distal amputation (above the ankle) in the study limb or non-study limb
• Target lesion involves an (pseudo-)aneurysm or is adjacent to an (pseudo-)aneurysm (within 5mm)
• Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications

Sponsors & Collaborators

• ID3 Medical: lead

Study Sites (13)

O.L.V. Hospital

Aalst, 9300, Belgium

RECRUITING

Imelda Hospital

Bonheiden, 2820, Belgium

RECRUITING

A.Z. Sint-Blasius

Dendermonde, 9200, Belgium

RECRUITING

Z.O.L.

Genk, 3600, Belgium

RECRUITING

Az Groeninge

Kortrijk, 8500, Belgium

RECRUITING

AZ Sint-Maarten

Mechelen, 2800, Belgium

NOT YET RECRUITING

A.Z. Jan Portaels

Vilvoorde, 1800, Belgium

RECRUITING

Maastricht UMC+

Maastricht, Limburg, 6229, Netherlands

RECRUITING

Dijklander hospital

Hoorn, North Holland, 1624, Netherlands

RECRUITING

St Antonius Hospital

Utrecht, Utrecht, 3543, Netherlands

RECRUITING

Noordwest ziekenhuisgroep

Alkmaar, 1815, Netherlands

RECRUITING

Bonifraterskie Centrum Medyczne

Krakow, 31-061, Poland

RECRUITING

Karol Marcinkowski Medical University

Poznan, 61-848, Poland

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Koen Deloose, MD

  A.Z. Sint-Blasius

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Vercauteren, MSc

CONTACT

+32 (0)52 25 27 45; office@id3medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All parties will know in what arm the study subject is randomized before the study procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The subjects will be randomly assigned in a 1:1 manner to treatment with either the Supera stent or endarterectomy.

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 16, 2020
• Study Start: May 5, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2); NL (4); BE (7)