HORIZON Prospective Clinical Investigation

NCT05234164 | Terminated

• 1 other identifier: 120884
• Study Type: interventional
• Target: 69
• Locations: 2 countries
• Sites: 2

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).

Conditions

Peripheral Arterial Disease

Keywords

stenotic lesions; Peripheral Arterial Disease; occluded lesions; Superficial Femoral Artery; nitinol stent; self-expanding stent; Chronic Limb-Threatening Ischemia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Improvement of Rutherford / Fontaine classification

  6- and 12-months

• Primary patency

  12-months

• Rate of stent fracture

  12- and 24-months

• Freedom from Target Lesion Revascularization

  1 month, 6-, 12- and 24-months

• Walking and mobility

  1 month, 6-, 12- and 24-months

Other Outcomes (1)

• Self-reported Quality of life

  1 month, 6-, 12- and 24-months

Study Arms (2)

EXIST 6F NiTi Stent System FLEX

EXPERIMENTAL

Stent implantation of lesions in the SFA graded with Fanelli 1 and 2, and lesions in the P1 segment of the proximal popliteal artery.

Device: EXIST 6F NiTi Stent System FLEX

EXIST 6F NiTi Stent System PULL

EXPERIMENTAL

Stent implantation of lesions in the SFA graded with 3 and 4.

Device: EXIST 6F NiTi Stent System PULL

Interventions

EXIST 6F NiTi Stent System FLEX DEVICE

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 FLEX

EXIST 6F NiTi Stent System PULL DEVICE

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.

EXIST 6F NiTi Stent System PULL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinical:
• Patient age 18 years or older
• 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
• Symptoms of peripheral arterial disease classified as Rutherford Category 2, 3 or 4 or Fontaine Class IIb or III
• The stenotic or occlusive lesion in Superficial Femoral Artery (SFA) and proximal popliteal artery, P1 segment, is considered suitable for stenting
• No underlying medical condition is present which would prevent the subject from performing the required testing or from completing the study.
• Stable medical condition
• Anatomical criteria:
• Included TASC II, A-B-C measured on pre- angio CT-scan (if CT-scan is standard of care)
• 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
• Patent ipsilateral iliac, popliteal (P2 and P3) and at least one tibial vessel

You may not qualify if:

• \- Clinical criteria:
• Subjects pregnant, breastfeeding or planning to become pregnant during the trial participation
• Documented life expectancy less than 24 months due to other medical co-morbid condition(s)
• Thrombophlebitis or deep vein thrombosis within the past 30 days.
• Unable to assume DAPT (Dual Antiplatelet Therapy)
• Concomitant renal failure with serum creatinine level \> 2.5 mg/dL (or \> 220 µmol/L) or GFR \< 30 ml/min/1,73 m2
• Unresolved neutropenia (white blood cell count \< 3,000 / µL) or thrombocytopenia (platelet count \< 80,000 / µL) at the time of the index procedure
• Unresolved bleeding disorder (INR ≥ 1.2) at the time of the index procedure
• Active gastrointestinal bleeding
• Anticoagulation therapy for other medical condition
• Anatomical criteria:
• 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)
• Previously stented ipsilateral SFA
• Prior peripheral vascular bypass surgery involving the target limb(s)
• Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion

Sponsors & Collaborators

• Qmedics AG: lead
• Policlinico di Monza: collaborator
• University Clinical Hospital of Bialystok: collaborator
• University Hospital, Catania: collaborator
• Erasmus Medical Center: collaborator
• University Hospital, Geneva: collaborator

Study Sites (2)

University Hospital of Catania

Catania, Sicily, 95123, Italy

Location

University Clinical Hospital of Bialystok

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Anita Patteet, MD

  Qmedics AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 10, 2022
• Study Start: December 15, 2021
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); PL (1)