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

NCT05445258 | Terminated DMC

• 1 other identifier: InnoCathAB®_01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerance

  Number of events, which are related to the medical device being tested

  up to 30 days after intervention

Secondary Outcomes (3)

• Procedural success

  till the end of the procedure

• Handling of the InnoCath AB® hyper-compliant balloon catheter

  throughout the entirety of the procedure

• Device deficiencies of the InnoCath AB® hyper-compliant balloon catheter

  throughout the entirety of the procedure

Study Arms (1)

InnoCath AB® Balloon

EXPERIMENTAL

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)

Device: InnoCath AB® hyper-compliant balloon catheter

Interventions

InnoCath AB® hyper-compliant balloon catheter 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)

InnoCath AB® Balloon

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• InnoRa GmbH: lead

Study Sites (2)

Klinik für Diagnostische und Interventionelle Radiologie Evangelisches Krankenhaus Hubertus

Berlin, 14129, Germany

Location

Klinik für Radiologie und Nuklearmedizin Martin-Luther-Krankenhaus

Berlin, 14193, Germany

Location

Study Officials

• Michael Werk, Dr

  Martin-Luther-Krankenhaus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 6, 2022
• Study Start: May 25, 2022
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

DE (2)