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

InnoRa

Status: Terminated

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

Treatments: Device: InnoCath AB® hyper-compliant balloon catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05445258

InnoCathAB®_01

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

InnoCath AB® Balloon

Experimental group

Description:

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)

Treatment:

Device: InnoCath AB® hyper-compliant balloon catheter