Clinical trial NCT05799131: Safety and Efficacy of the QBX Peripheral Balloon Expandable Stent System in Peripheral Artery Disease (PAD)
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral Arterial Disease
Lead sponsor: QualiMed Innovative Medizinprodukte GmbH
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.


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.

Primary outcomes:
measure: To evaluate the cumulative rate of MAVE.
timeFrame: 12-months follow-up
Secondary outcomes:
measure: Rate of subjects with Vascular Access Site Complications (VASCs) within the first 24h after the index-procedure
timeFrame: 24 hours
measure: Intra-operative complication rate.
timeFrame: Index-procedure
measure: Post-operative complication rate.
timeFrame: 12-months follow-up
measure: Intra-operative absence of bleeding at puncture site.
timeFrame: Index-procedure
measure: Re-occlusion rate.
timeFrame: 12-months follow-up
measure: Target Vessel Revascularization (TVR) rate.
timeFrame: 12-months follow-up
measure: Amputation rate
timeFrame: 12-months follow-up
measure: Procedural success.
timeFrame: Index-procedure
measure: Technical success
timeFrame: Index-procedure
measure: Device success.
timeFrame: Index-procedure
measure: Device performance.
timeFrame: Index-procedure
measure: Reduction in percentage diameter stenosis post-procedure compared to pre-procedure.
timeFrame: Index-procedure
measure: Artery patency.
timeFrame: 1-month follow-up
measure: Artery patency.
timeFrame: 6-months follow-up
measure: Artery patency.
timeFrame: 12-months follow-up
measure: Return to normal activity.
timeFrame: 1-month follow-up
measure: Distribution of Rutherford classes during follow-up as compared to baseline.
timeFrame: 1-month follow-up
measure: Distribution of Rutherford classes during follow-up as compared to baseline.
timeFrame: 6-months follow-up
measure: Distribution of Rutherford classes during follow-up as compared to baseline.
timeFrame: 12-months follow-up
measure: Distribution of Fontaine stages during follow-up as compared to baseline.
timeFrame: 1-month follow-up
measure: Distribution of Fontaine stages during follow-up as compared to baseline.
timeFrame: 6-months follow-up
measure: Distribution of Fontaine stages during follow-up as compared to baseline.
timeFrame: 12-months follow-up
measure: Primary sustained clinical improvement at 12 months.
timeFrame: 12-months follow-up
measure: Secondary sustained clinical improvement at 12 months.
timeFrame: 12-months follow-up
measure: Improvement in disease-related health status, functioning and quality of life at follow-up as compared to baseline.
timeFrame: 1-month follow-up
measure: Improvement in disease-related health status, functioning and quality of life at follow-up as compared to baseline.
timeFrame: 6-months follow-up
measure: Improvement in disease-related health status, functioning and quality of life at follow-up as compared to baseline.
timeFrame: 12-months follow-up
measure: Ankle Brachial Index (ABI) during follow-up as compared to baseline.
timeFrame: 1-month follow-up
measure: Ankle Brachial Index (ABI) during follow-up as compared to baseline.
timeFrame: 6-months follow-up
measure: Ankle Brachial Index (ABI) during follow-up as compared to baseline.
timeFrame: 12-months follow-up
measure: Occurrence of prolonged hospitalization compared to local standard of care (SOC).
timeFrame: Immediately after the procedure
measure: Time taken off from work for the procedure
timeFrame: 1-month follow-up
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg Genk
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Vlaanderen
city: Brussels
country: Belgium
facility: HIS IZZ
Study officials:
References: