Safety and Efficacy of the QBX Peripheral Balloon Expandable Stent System in Peripheral Artery Disease (PAD)

NCT ID: NCT05799131

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-07-31

Brief Summary

This study aims to evaluate the safety and performance of the QBX stent system in the treatment of PAD by reporting of peri- and postoperative complications, including major adverse vascular events (MAVE), Vascular Access Site Complications (VASCs) and bleeding at puncture site, and by evaluating the prevalence of Target Vessel Revascularization (TVR), amputations, procedural success, device performance, reduction in percentage diameter stenosis post-procedure compared to pre-procedure, artery patency, return to normal activity, Rutherford and Fontaine classification, quality of life (QoL), Ankle Brachial Index (ABI), and hospital- and patient-related costs in a prospectively maintained database.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

QBX (5F/6F) Peripheral Balloon Expandable Stent System

QBX (5F/6F) Peripheral Balloon Expandable Stent System

Intervention Type: DEVICE

The QBX Stent System is a flexible, balloon expandable stent, made of a cobalt chromium alloy manufactured by QualiMed Innovative Medizinprodukte GmbH. The design is suitable for peripheral vessel diameters from 5 to 10 mm.

The QBX Stent System is available as 6F and 5F variations where the 6F system is mounted on an 0.035" over-the-wire delivery system, and the 5F is mounted on an 0.018" over-the-wire delivery system. Both are available in a full range of diameters and lengths.

Interventions

QBX (5F/6F) Peripheral Balloon Expandable Stent System

The QBX Stent System is a flexible, balloon expandable stent, made of a cobalt chromium alloy manufactured by QualiMed Innovative Medizinprodukte GmbH. The design is suitable for peripheral vessel diameters from 5 to 10 mm.

The QBX Stent System is available as 6F and 5F variations where the 6F system is mounted on an 0.035" over-the-wire delivery system, and the 5F is mounted on an 0.018" over-the-wire delivery system. Both are available in a full range of diameters and lengths.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient eligible for implantation of a peripheral balloon-expandable stent.
• Target lesion is an occlusion or diameter stenosis is ≥50% by visual estimate.
• Target lesion is a de novo or restenotic lesion.
• Target lesion is located in the external iliac artery (EIA), internal iliac artery (IIA), common iliac artery (CIA), superficial femoral artery (SFA) and/or deep femoral artery (DFA). Bilateral treatment of the target lesions is allowed. There are no restrictions on the number of target lesions treated with QBX or the number of stents used. Kissing stents and overlapping stents are allowed to treat the target lesions.
• Patient suffers from mild to intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4-5).
• Patients with TASC A, B, C and D lesions.
• Patient ≥ 18 years of age at study entry.
• Patient and investigator signed and dated the informed consent form prior to the index-procedure.

Exclusion Criteria

• Age < 18 y.
• Pregnant women, women who are currently breastfeeding, women of childbearing potential who are not using an effective method of contraception, or women planning to become pregnant during the course of the study.
• Patients with Rutherford 0 and 6.
• Patient received a different stent device than the study device for the target lesion.
• Target lesion cannot be crossed with a guidewire (e.g. heavily calcified or excessively tortuous target lesion).
• Reference vessel diameter is not suitable for the available stent design.
• Target lesion was previously treated with a stent.
• Target lesion is in a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis.
• Presence of significant stenosis (≥50%) or occlusion of inflow tract not successfully treated before or during the index-procedure (success is measured as < 30% residual stenosis and absence of distal embolization).
• Outflow: In case of treatment of iliac arteries: Inadequate distal runoff with > 50% stenosis of either the common femoral artery or both the superficial and deep femoral arteries. In case of treatment of the SFA: Absence of at least one patent runoff vessel with ≤ 50% stenosis throughout its course (i.e., confirmed in-line patency to the level of the foot). Outflow can be treated before or during the index-procedure (success is measured as < 30% residual stenosis and absence of distal embolization).
• Presence of active inflammation at the planned access site.
• Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index-procedure.
• Patients in severe renal failure (estimated Glomerular filtration rate (eGFR) < 25 mL/min/1.73m). Lab results are maximum 30 days old.
• Patient has a persistent acute intraluminal thrombus of the target lesion.
• Target lesion is in an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
• Patient has an abdominal aortic aneurysm contiguous with an iliac artery target lesion.
• Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
• Contraindication for anti-coagulation therapy (coagulopathy, etc.).
• Patient has a known intolerance to contrast agents. If hypersensitivity to contrast agents in patients with prior reactions could be improved by premedication and changing the contrast agent, the patient can be included in the study.
• Patients has a known hypersensitivity to the stent material (L605).
• Patient has a life expectancy of <12 months.
• Patient has a planned surgical intervention/procedure, interfering with the study (results), within 30 days of the study procedure.
• Patient is considered to be hemodynamically unstable at onset of index-procedure.
• Patient is currently participating in a confounding study.
• Patient is unable to comply with the protocol or proposed follow-up visits.
• Patient is unable / unwilling to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

QualiMed Innovative Medizinprodukte GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ziekenhuis Oost-Limburg Genk

Genk, Limburg, Belgium

Jessa Ziekenhuis

Hasselt, Limburg, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

HIS IZZ

Brussels, , Belgium

Countries

Belgium

Central Contacts

Dorien Haesen, PhD

Role: CONTACT

dorien.haesen@archerresearch.eu

+32 11 28 69 48

Facility Contacts

Wouter Lansink, Dr.

Role: primary

Bert Du Pont, Dr.

Role: primary

Philip Lerut, Dr.

Role: primary

Gregory Callebaut, Dr.

Role: primary

Other Identifiers

QBX-RADAR

Identifier Type: -

Identifier Source: org_study_id