Clinical trial NCT05234164: HORIZON Prospective Clinical Investigation
Official title: HORIZON. Clinical Investigation of the Qmedics EXIST NiTi Stent Type FLEX & PULL in Adults With Peripheral Artery Disease (PAD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: stenotic lesions
Peripheral Arterial Disease
occluded lesions
Superficial Femoral Artery
nitinol stent
self-expanding stent
Chronic Limb-Threatening Ischemia
Lead sponsor: Qmedics AG
Sponsor class: INDUSTRY
Collaborators: name: Policlinico di Monza
name: University Clinical Hospital of Bialystok
name: University Hospital, Catania
name: Erasmus Medical Center
name: University Hospital, Geneva
First posted: 2022-02-10
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects requiring treatment of the SFA will undergo a calcification review based on the Fanelli classification. Subjects graded with Fanelli 1 or 2, and subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Exist 6F NiTi Stent type FLEX.

Subject graded with Fanelli 3 and 4 will be treated with the Exist 6F NiTi Stent PULL.
Primary purpose: TREATMENT

Brief summary: The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX \& PULL in a prospective investigation for the treatment of adult patients with de novo or re-stenotic symptomatic atherosclerotic lesions in Peripheral Artery Disease (PAD) requiring treatment of the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (P1 segment).

Detailed description: This is a multicenter, prospective study with clinical and radiographic follow-up for 24 months months post-procedure. Approximately two hundred thirty subjects will be enrolled (115 subjects will receive the FLEX type and 115 subjects the PULL type) in several centers, minimum 10 patients per investigational center. All patients will be evaluated at 30 days and 6-, 12- and 24-months post-index procedure.

Eligibility criteria: Inclusion Criteria:

- Clinical:

1. Patient age 18 years or older
2. Subject is willing and able to provide consent before any study specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits
3. Symptoms of peripheral arterial disease classified as Rutherford Category 2, 3 or 4 or Fontaine Class IIb or III
4. The stenotic or occlusive lesion in Superficial Femoral Artery (SFA) and proximal popliteal artery, P1 segment, is considered suitable for stenting
5. No underlying medical condition is present which would prevent the subject from performing the required testing or from completing the study.
6. Stable medical condition

   * Anatomical criteria:
7. Included TASC II, A-B-C measured on pre- angio CT-scan (if CT-scan is standard of care)
8. Lesions must be one or multiple that can be treated with maximum two stents, maximum one overlapping and maximum length of the stent 25 cm
9. Patent ipsilateral iliac, popliteal (P2 and P3) and at least one tibial vessel

Exclusion Criteria:

- Clinical criteria:

1. Subjects pregnant, breastfeeding or planning to become pregnant during the trial participation
2. Documented life expectancy less than 24 months due to other medical co-morbid condition(s)
3. Thrombophlebitis or deep vein thrombosis within the past 30 days.
4. Unable to assume DAPT (Dual Antiplatelet Therapy)
5. Concomitant renal failure with serum creatinine level \> 2.5 mg/dL (or \> 220 µmol/L) or GFR \< 30 ml/min/1,73 m2
6. Unresolved neutropenia (white blood cell count \< 3,000 / µL) or thrombocytopenia (platelet count \< 80,000 / µL) at the time of the index procedure
7. Unresolved bleeding disorder (INR ≥ 1.2) at the time of the index procedure
8. Active gastrointestinal bleeding
9. Anticoagulation therapy for other medical condition

   * Anatomical criteria:
10. Target lesion(s) received previous treatment within 30 days prior to enrolment (point of enrolment is defined as the time when the trial device enters the body)
11. Previously stented ipsilateral SFA
12. Prior peripheral vascular bypass surgery involving the target limb(s)
13. Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion
14. Target lesion requires the use of cutting balloons, atherectomy or drug coated balloons (DCB) during the intervention

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
measure: Major Adverse Events
timeFrame: 1 month
Secondary outcomes:
measure: Improvement of Rutherford / Fontaine classification
timeFrame: 6- and 12-months
measure: Primary patency
timeFrame: 12-months
measure: Rate of stent fracture
timeFrame: 12- and 24-months
measure: Freedom from Target Lesion Revascularization
timeFrame: 1 month, 6-, 12- and 24-months
measure: Walking and mobility
timeFrame: 1 month, 6-, 12- and 24-months
measure: Patency rate
timeFrame: 24 months
measure: Major Adverse Events
timeFrame: 24 months
Other outcomes:
measure: Self-reported Quality of life
timeFrame: 1 month, 6-, 12- and 24-months
Locations:
city: Catania
country: Italy
facility: University Hospital of Catania
state: Sicily
city: Białystok
country: Poland
facility: University Clinical Hospital of Bialystok
state: Podlaskie Voivodeship
Study officials:
affiliation: Qmedics AG
name: Anita Patteet, MD
role: STUDY_DIRECTOR
References: