HORIZON Prospective Clinical Investigation

Peripheral Arterial Disease Clinical Trial

Official title:

HORIZON. Clinical Investigation of the Qmedics EXIST NiTi Stent Type FLEX & PULL in Adults With Peripheral Artery Disease (PAD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05234164
• Other study ID #: 120884
• Status: Terminated
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: November 17, 2023

Study information

• Verified date: February 2024
• Source: Qmedics AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• EXIST 6F NiTi Stent System FLEX
Subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Exist 6F NiTi Stent FLEX type. Subjects requiring treatment of the SFA will undergo an additional calcification review based on the Fanelli classification. Subjects graded with Fanelli 1 or 2 will be treated with the Exist 6F NiTi Stent FLEX type.
• EXIST 6F NiTi Stent System PULL
Subjects requiring treatment of the SFA will undergo a calcification review based on the Fanelli classification. Subjects graded with Fanelli grade 3 and 4 will be treated with the Exist 6F NiTi Stent PULL type.

Locations

Country	Name	City	State
Italy	University Hospital of Catania	Catania	Sicily
Poland	University Clinical Hospital of Bialystok	Bialystok	Podlaskie Voivodeship

Sponsors (6)

Lead Sponsor	Collaborator
Qmedics AG	Erasmus Medical Center, Policlinico di Monza, University Clinical Hospital of Bialystok, University Hospital, Catania, University Hospital, Geneva

Countries where clinical trial is conducted

Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported Quality of life	Improvement of quality of life is assessed by change in the 36-Item Short Form Survey (SF-36) score from baseline.	1 month, 6-, 12- and 24-months
Primary	Primary patency	The primary patency rate (defined as freedom from more than = 50% restenosis) at 12 months post-procedure as measured by Peak Systolic Velocity ratio (PSVr) assessed with Duplex ultrasound (DUS). A PSVr = 2,5 suggests a reduction in the luminal diameter >50%.	12 months
Primary	Major Adverse Events	Freedom from procedure- or stent-related Major Adverse Events (MAEs) at 30-days post index-procedure will be reported. MAE is defined as all causes of death and target limb major amputation, defined as amputation of the lower limb at the ankle level or above.	1 month
Secondary	Improvement of Rutherford / Fontaine classification	Clinical success Defined as improvement of Rutherford / Fontaine classification of one class or more as compared to the pre-procedure and an ankle-brachial index improvement (ABI) by = 0.15.	6- and 12-months
Secondary	Primary patency	Compare the Exist 6F NiTi stent primary patency with >50% of subjects with peripheral artery disease with literature data.	12-months
Secondary	Rate of stent fracture	Stent fracture rate is evaluated with x-ray. Stent fracture is defined according to classification on x-ray.	12- and 24-months
Secondary	Freedom from Target Lesion Revascularization	Defined as the absence of revascularization (by any means) of the target lesion (fTLR).	1 month, 6-, 12- and 24-months
Secondary	Walking and mobility	Improvement of walking and mobility is assessed by change in the 36-Item Short Form Survey (SF-36) score from baseline.	1 month, 6-, 12- and 24-months
Secondary	Patency rate	Patency rate as measured by Peak Systolic Velocity ratio (PSVr) assessed with Duplex ultrasound (DUS). A PSVr = 2,5 suggests a reduction in the luminal diameter >50%.	24 months
Secondary	Major Adverse Events	Procedure- or stent-related Major Adverse Events (MAEs) post index-procedure will be reported. MAE is defined as all causes of death and target limb major amputation, defined as amputation of the lower limb at the ankle level or above.	24 months