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

Evaluation of the Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon Catheters in Peripheral Arteries

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.

Study Overview

• Status: Terminated
• Conditions: Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II
• Intervention / Treatment: Device: InnoCath AB® hyper-compliant balloon catheter

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14129
    • Klinik für Diagnostische und Interventionelle Radiologie Evangelisches Krankenhaus Hubertus
  • Berlin, Germany, 14193
    • Klinik für Radiologie und Nuklearmedizin Martin-Luther-Krankenhaus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerance	Number of events, which are related to the medical device being tested	up to 30 days after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	defined as technical success (ability of the InnoCath AB® hyper-compliant bal-loon catheter to perform as intended, inflation of the device at the lesion site and retraction of the balloon catheter through the introductory sheath) in the ab-sence of vessel rupture, distal embolization, thrombosis, access complications, and major adverse cardiovascular events (cardiac death, myocardial infarction, stroke) as a consequence of the procedure and related to the study device till the end of the procedure	till the end of the procedure
Handling of the InnoCath AB® hyper-compliant balloon catheter	The handling of the InnoCath AB® hyper-compliant balloon catheter will be evaluated by the investigator, who assesses various parameters using a scale from 0-2, where 0 describes the better outcome; e.g. balloon deflation and withdrawal of balloon catheter: 0=easy, without any problems, 1=difficult, abnormal, 2=not possible.	throughout the entirety of the procedure
Device deficiencies of the InnoCath AB® hyper-compliant balloon catheter	The device deficiencies of the InnoCath AB® hyper-compliant balloon catheter will be assessed by the investigator as free-text. Device deficiencies means any inadequacy in the identity, quali-ty, durability, reliability, safety or performance of an investigational device, including malfunc-tion, use errors or inadequacy in information supplied by the manufacturer	throughout the entirety of the procedure

Collaborators and Investigators

• Sponsor: InnoRa GmbH
• Investigators: Principal Investigator: Michael Werk, Dr, Martin-Luther-Krankenhaus

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): August 2, 2022
• Study Completion (Actual): August 2, 2022

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: InnoCathAB®_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No