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HORIZON Prospective Clinical Investigation

NCT05234164 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-02-14

No results posted yet for this study

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

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

  • Policlinico di Monza

    collaborator UNKNOWN

  • University Clinical Hospital of Bialystok

    collaborator UNKNOWN

  • University Hospital, Catania

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • University Hospital, Geneva

    collaborator OTHER

  • Qmedics AG

    lead INDUSTRY

Principal Investigators

  • Anita Patteet, MD · Qmedics AG

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2023-11-17
Completion
2023-11-17

Countries

  • Italy
  • Poland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234164 on ClinicalTrials.gov