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

NCT05799131 | Unknown

• 1 other identifier: QBX-RADAR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the cumulative rate of MAVE.

  MAVE is defined as: 1. Device- or procedure-related death; 2. Target Lesion Revascularization (TLR) at 12 months, defined as a repeated procedure (endovascular or open surgery) due to a problem arising from the lesion (+1 cm proximally and distally to include edge phenomena) initially treated; 3. Device-related distal embolization that required hospitalization and/or subsequent intervention.

  12-months follow-up

Secondary Outcomes (32)

• Rate of subjects with Vascular Access Site Complications (VASCs) within the first 24h after the index-procedure

  24 hours

• Intra-operative complication rate.

  Index-procedure

• Post-operative complication rate.

  12-months follow-up

• Intra-operative absence of bleeding at puncture site.

  Index-procedure

• Re-occlusion rate.

  12-months follow-up

Study Arms (1)

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

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

Interventions

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

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

Eligibility Criteria

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

Study Population

Patients with PAD which are indicated to receive treatment with the QBX balloon-expandable stent and 5/6-French system through a femoral access with the aim to improve the vessel lumen diameter of target lesions (de novo and re-stenoses) in native peripheral arteries, e.g. external iliac artery (EIA), internal iliac artery (IIA), common iliac artery (CIA), superficial femoral artery (SFA) and deep femoral artery (DFA).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• QualiMed Innovative Medizinprodukte GmbH: lead

Study Sites (4)

Ziekenhuis Oost-Limburg Genk

Genk, Limburg, 3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

AZ Groeninge

Kortrijk, West-Vlaanderen, 8500, Belgium

Location

HIS IZZ

Brussels, 1040/1050, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dorien Haesen, PhD

CONTACT

+32 11 28 69 48; dorien.haesen@archerresearch.eu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 5, 2023
• Study Start: May 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: April 5, 2023

Record last verified: 2023-03

Locations

BE (4)