Peripheral Arterial DiseaseQBX-RADARNCT05799131
Safety and Efficacy of the QBX Peripheral Balloon Expandable Stent System in Peripheral Artery Disease (PAD)
An observational study of Peripheral Arterial Disease, run by QualiMed Innovative Medizinprodukte GmbH at 4 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- QBX (5F/6F) Peripheral Balloon Expandable Stent System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesBelgium
- Study dates
- 1 May 2023to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
HIS IZZ
Brussels, 1040/1050
Gregory Callebaut, Dr.
Ziekenhuis Oost-Limburg Genk
Genk, Limburg, 3600
Wouter Lansink, Dr.
Jessa Ziekenhuis
Hasselt, Limburg, 3500
Bert Du Pont, Dr.
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500
Philip Lerut, Dr.
About this study
Official title: QBX (5F/6F) Peripheral Balloon Expandable Stent System for the Treatment of Peripheral Artery Disease (PAD): Assessing Safety and Clinical Performance up to 12-months Follow-up
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
- Being tested
- QBX (5F/6F) Peripheral Balloon Expandable Stent System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QBX (5F/6F) Peripheral Balloon Expandable Stent SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| QBX (5F/6F) Peripheral Balloon Expandable Stent System | Not described Receives: Device: QBX (5F/6F) Peripheral Balloon Expandable Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the cumulative rate of MAVE.
MAVE is defined as:
- Device- or procedure-related death;
- 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;
- Device-related distal embolization that required hospitalization and/or subsequent intervention.
Measured: 12-months follow-up
Secondary outcomes (32)
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
Measured: 24 hours
Intra-operative complication rate.
Measured: Index-procedure
Post-operative complication rate.
Measured: 12-months follow-up
Intra-operative absence of bleeding at puncture site.
Measured: Index-procedure
Re-occlusion rate.
Re-occlusion is defined as complete occlusion of the target lesion initially treated.
Measured: 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.
Measured: 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.
Measured: 12-months follow-up
Procedural success.
Procedural success is defined as a combination of technical success, device success and absence of procedural complications.
Measured: 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.
Measured: Index-procedure
Device success.
Device success is defined as exact deployment of the device according to the instructions for use.
Measured: 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
Measured: Index-procedure
Reduction in percentage diameter stenosis post-procedure compared to pre-procedure.
Assessed via CT angio.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-months follow-up
Return to normal activity.
The number of days until return to normal activities will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-months follow-up
Ankle Brachial Index (ABI) during follow-up as compared to baseline.
Measured: 1-month follow-up
Ankle Brachial Index (ABI) during follow-up as compared to baseline.
Measured: 6-months follow-up
Ankle Brachial Index (ABI) during follow-up as compared to baseline.
Measured: 12-months follow-up
Occurrence of prolonged hospitalization compared to local standard of care (SOC).
When the patient leaves the hospital after the procedure.
Measured: 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
Measured: 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QualiMed Innovative Medizinprodukte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799131
- Sponsor's protocol ID
- QBX-RADAR
- Acronym
- QBX-RADAR
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QBX (5F/6F) Peripheral Balloon Expandable Stent System for the Treatment of Peripheral Artery Disease (PAD): Assessing Safety and Clinical Performance up to 12-months Follow-up
- ClinicalTrials.gov ID
- NCT05799131
- Acronym / sponsor ID
- QBX-RADAR / QBX-RADAR
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- QualiMed Innovative Medizinprodukte GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QBX (5F/6F) Peripheral Balloon Expandable Stent System | – | Device: QBX (5F/6F) Peripheral Balloon Expandable Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (26 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QBX (5F/6F) Peripheral Balloon Expandable Stent SystemThe 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. | Device | QBX (5F/6F) Peripheral Balloon Expandable Stent System |
Primary outcome
To evaluate the cumulative rate of MAVE.
Time frame: 12-months follow-up
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.
32 secondary outcomes
Rate of subjects with Vascular Access Site Complications (VASCs) within the first 24h after the index-procedure
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.
Time frame: 12-months follow-up
Target Vessel Revascularization (TVR) rate.
Time frame: 12-months follow-up
Amputation rate
Time frame: 12-months follow-up
Procedural success.
Time frame: Index-procedure
Technical success
Time frame: Index-procedure
Device success.
Time frame: Index-procedure
Device performance.
Time frame: Index-procedure
Reduction in percentage diameter stenosis post-procedure compared to pre-procedure.
Time frame: Index-procedure
Artery patency.
Time frame: 1-month follow-up
Artery patency.
Time frame: 6-months follow-up
Artery patency.
Time frame: 12-months follow-up
Return to normal activity.
Time frame: 1-month follow-up
Distribution of Rutherford classes during follow-up as compared to baseline.
Time frame: 1-month follow-up
Distribution of Rutherford classes during follow-up as compared to baseline.
Time frame: 6-months follow-up
Distribution of Rutherford classes during follow-up as compared to baseline.
Time frame: 12-months follow-up
Distribution of Fontaine stages during follow-up as compared to baseline.
Time frame: 1-month follow-up
Distribution of Fontaine stages during follow-up as compared to baseline.
Time frame: 6-months follow-up
Distribution of Fontaine stages during follow-up as compared to baseline.
Time frame: 12-months follow-up
Primary sustained clinical improvement at 12 months.
Time frame: 12-months follow-up
Secondary sustained clinical improvement at 12 months.
Time frame: 12-months follow-up
Improvement in disease-related health status, functioning and quality of life at follow-up as compared to baseline.
Time frame: 1-month follow-up
Improvement in disease-related health status, functioning and quality of life at follow-up as compared to baseline.
Time frame: 6-months follow-up
Improvement in disease-related health status, functioning and quality of life at follow-up as compared to baseline.
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).
Time frame: Immediately after the procedure
Time taken off from work for the procedure
Time frame: 1-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by QualiMed Innovative Medizinprodukte GmbH at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorien Haesen, PhD (+32 11 28 69 48, dorien.haesen@archerresearch.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the cumulative rate of MAVE. (time frame: 12-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.