Not yet recruitingNCT05799131QBX-RADARUpdated Apr 5, 2023

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

An observational study in Peripheral Arterial Disease, sponsored by QualiMed Innovative Medizinprodukte GmbH. Not yet recruiting at 4 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-05.

Sponsored by QualiMed Innovative Medizinprodukte GmbH · Observational

From the registry’s dates

Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 100
Ages: 18 Years and older
Sex: All

Study 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 studied

Peripheral Arterial Disease

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In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's planned enrollment of 100 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

QualiMed Innovative Medizinprodukte GmbH is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
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).

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

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.

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 100 participants (estimated)
Patient registry: No

Groups and cohorts

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

Interventions

DeviceQBX (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.

What researchers measure

Primary outcomes

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.
Time frame: 12-months follow-up

Secondary outcomes

Rate of subjects with Vascular Access Site Complications (VASCs) within the first 24h after the index-procedure
VASCs are defined as: * Hematoma/bleeding requiring transfusion * Arterial/venous occlusion/thrombosis * Severe vasospasm * Intimal injury/dissection * Pseudoaneurysm * Arteriovenous fistula * Vascular perforation or rupture * Arterial embolization distal to treatment site * Neuropathy * Retroperitoneal hematoma
Time frame: 24 hours
Intra-operative complication rate.
Time frame: Index-procedure
Post-operative complication rate.
Time frame: 12-months follow-up
Intra-operative absence of bleeding at puncture site.
Time frame: Index-procedure
Re-occlusion rate.
Re-occlusion is defined as complete occlusion of the target lesion initially treated.
Time frame: 12-months follow-up
Target Vessel Revascularization (TVR) rate.
TVR is defined as a procedure (endovascular or open surgical) due to a problem arising in the target vessel remote from the target lesion(s) initially treated.
Time frame: 12-months follow-up
Amputation rate
Minor (below the ankle) and major (above the ankle) amputation rate at 12 months will be assessed. Major amputation rates must be reported as below-the-knee and above-the-knee amputations.
Time frame: 12-months follow-up
Procedural success.
Procedural success is defined as a combination of technical success, device success and absence of procedural complications.
Time frame: Index-procedure
Technical success
Technical success is defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less than 30% residual diameter reduction of the treated lesion on completion angiography.
Time frame: Index-procedure
Device success.
Device success is defined as exact deployment of the device according to the instructions for use.
Time frame: Index-procedure
Device performance.
Scored using the following components and a dedicated Scoring System (1: Very good, 2: Good, 3: Sufficient, Poor: 4): * Insertion through introducer sheath * Tracking to target site over guidewire * Crossability through of the lesion * Catheter pushability * Catheter shaft kink resistance * Stent radiopacity * Inflation time to Nominal diameter * Deflation time * Stent apposition * General usability of the QBX device
Time frame: Index-procedure
Reduction in percentage diameter stenosis post-procedure compared to pre-procedure.
Assessed via CT angio.
Time frame: Index-procedure
Artery patency.
A duplex ultrasound will be performed to evaluate artery patency. If reliable duplex ultrasound assessment of artery patency is not possible, ABI is a good indication of patency. If ABI is abnormal and the patient is experiencing symptoms, a CT angio or other imaging module might be performed according to standard of care.
Time frame: 1-month follow-up
Artery patency.
A duplex ultrasound will be performed to evaluate artery patency. If reliable duplex ultrasound assessment of artery patency is not possible, ABI is a good indication of patency. If ABI is abnormal and the patient is experiencing symptoms, a CT angio or other imaging module might be performed according to standard of care.
Time frame: 6-months follow-up
Artery patency.
A duplex ultrasound will be performed to evaluate artery patency. If reliable duplex ultrasound assessment of artery patency is not possible, ABI is a good indication of patency. If ABI is abnormal and the patient is experiencing symptoms, a CT angio or other imaging module might be performed according to standard of care.
Time frame: 12-months follow-up
Return to normal activity.
The number of days until return to normal activities will be assessed.
Time frame: 1-month follow-up
Distribution of Rutherford classes during follow-up as compared to baseline.
The percentage of patients with Rutherford classes 0 to 6 will be determined.
Time frame: 1-month follow-up
Distribution of Rutherford classes during follow-up as compared to baseline.
The percentage of patients with Rutherford classes 0 to 6 will be determined.
Time frame: 6-months follow-up
Distribution of Rutherford classes during follow-up as compared to baseline.
The percentage of patients with Rutherford classes 0 to 6 will be determined.
Time frame: 12-months follow-up
Distribution of Fontaine stages during follow-up as compared to baseline.
The percentage of patients with Fontaine stages I to IV will be determined.
Time frame: 1-month follow-up
Distribution of Fontaine stages during follow-up as compared to baseline.
The percentage of patients with Fontaine stages I to IV will be determined.
Time frame: 6-months follow-up
Distribution of Fontaine stages during follow-up as compared to baseline.
The percentage of patients with Fontaine stages I to IV will be determined.
Time frame: 12-months follow-up
Primary sustained clinical improvement at 12 months.
Primary sustained clinical improvement is defined as sustained upward shift of at least one category on the Rutherford/Fontaine classification without the need for repeated TLR in surviving patients.
Time frame: 12-months follow-up
Secondary sustained clinical improvement at 12 months.
Secondary sustained clinical improvement is defined as sustained upward shift of at least one category on the Rutherford/Fontaine classification including the need for repeated TLR in surviving patients.
Time frame: 12-months follow-up
Improvement in disease-related health status, functioning and quality of life at follow-up as compared to baseline.
This is scored by the Walking Impairment Questionnaire and EQ-5D questionnaire.
Time frame: 1-month follow-up
Improvement in disease-related health status, functioning and quality of life at follow-up as compared to baseline.
This is scored by the Walking Impairment Questionnaire and EQ-5D questionnaire.
Time frame: 6-months follow-up
Improvement in disease-related health status, functioning and quality of life at follow-up as compared to baseline.
This is scored by the Walking Impairment Questionnaire and EQ-5D questionnaire.
Time frame: 12-months follow-up
Ankle Brachial Index (ABI) during follow-up as compared to baseline.
Time frame: 1-month follow-up
Ankle Brachial Index (ABI) during follow-up as compared to baseline.
Time frame: 6-months follow-up
Ankle Brachial Index (ABI) during follow-up as compared to baseline.
Time frame: 12-months follow-up
Occurrence of prolonged hospitalization compared to local standard of care (SOC).
When the patient leaves the hospital after the procedure.
Time frame: Immediately after the procedure
Time taken off from work for the procedure
Consists of: * Initial sick leave after the surgery * Additional sick leave * Leave taken by friends/relatives for patient care
Time frame: 1-month follow-up

Study locations

4 sites

Ziekenhuis Oost-Limburg Genk
Genk, Limburg 3600, Belgium
- Wouter Lansink, Dr. · Contact
Jessa Ziekenhuis
Hasselt, Limburg 3500, Belgium
- Bert Du Pont, Dr. · Contact
AZ Groeninge
Kortrijk, West-Vlaanderen 8500, Belgium
- Philip Lerut, Dr. · Contact
HIS IZZ
Brussels, 1040/1050, Belgium
- Gregory Callebaut, Dr. · Contact

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05799131
Lead sponsor: QualiMed Innovative Medizinprodukte GmbH
Responsible party: Sponsor
First posted: Apr 5, 2023
Start date: May 1, 2023 (estimated)
Primary completion: Jun 30, 2025 (estimated)
Completion: Jul 31, 2025 (estimated)
Last update: Apr 5, 2023

Study contacts

Dorien Haesen, PhD

Contact

dorien.haesen@archerresearch.eu

+32 11 28 69 48

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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