Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2022-08-02

Brief Summary

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This is a 'first in man' study to demonstrate compliance with the general safety and performance requirements of Regulation (EU) 2017/745 on medical devices (MDR) Annex I as part of the clinical evaluation and for the application of CE-marking. The aim of the study is to evaluate the safety and tolerability of the application and the success rate of the InnoCath AB® hyper-compliant balloon catheter after PTA in peripheral arteries.

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Detailed Description

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Conditions

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Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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InnoCath AB® Balloon

endovascular treatment of lesions in the superficial femoral artery (SFA) and/or popliteal artery pars I/II without further luminal widening, and/or for short-term interruption of blood flow with the InnoCath AB® hyper-compliant balloon cathe-ters (100 or 200 mm length)

Group Type EXPERIMENTAL

InnoCath AB® hyper-compliant balloon catheter

Intervention Type DEVICE

endovascular treatment of lesions in the superficial femoral artery (SFA) and/or popliteal artery pars I/II without further luminal widening, and/or for short-term interruption of blood flow with the InnoCath AB® hyper-compliant balloon cathe-ters (100 or 200 mm length)

Interventions

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InnoCath AB® hyper-compliant balloon catheter

endovascular treatment of lesions in the superficial femoral artery (SFA) and/or popliteal artery pars I/II without further luminal widening, and/or for short-term interruption of blood flow with the InnoCath AB® hyper-compliant balloon cathe-ters (100 or 200 mm length)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age
* Patients with peripheral arterial occlusive disease and intended for endovascular therapy in the SFA and/or popliteal artery pars I/II
* Patients suitable for endovascular therapy in the SFA and/or popliteal artery pars I/II with a hyper-compliant balloon without further luminal widening
* Target vessels with a sufficient "runoff" to the foot with at least one vessel
* Rutherford classification 1-4 if physical and medicinal therapies have not been successful

Exclusion Criteria

* Aneurysms at the site of inflation
* Application directly in the area of large vessel wall injuries with heavy bleeding
* Rutherford classification 5 and 6

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No