Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/IIHYPERNCT05445258
Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon
A study testing InnoCath AB® hyper-compliant balloon catheter in people with Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II, run by InnoRa GmbH at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II
- What is being tested?
- InnoCath AB® hyper-compliant balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesGermany
- Study dates
- 25 May 2022to 2 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Germany2 sites
Klinik für Diagnostische und Interventionelle Radiologie Evangelisches Krankenhaus Hubertus
Berlin, 14129
Klinik für Radiologie und Nuklearmedizin Martin-Luther-Krankenhaus
Berlin, 14193
About this study
Official title: 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.
- Being tested
- InnoCath AB® hyper-compliant balloon catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnoCath AB® hyper-compliant balloon catheterDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: InnoCath AB® hyper-compliant balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance
Number of events, which are related to the medical device being tested
Measured: up to 30 days after intervention
Secondary outcomes (3)
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
Measured: 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.
Measured: 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
Measured: throughout the entirety of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start25 May 2022
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Why it stopped: Design of the study device will be modified
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoRa GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Werk, Dr, Principal investigator, Martin-Luther-Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445258
- Sponsor's protocol ID
- InnoCathAB®_01
- Acronym
- HYPER
- Status last verified
- Sep 2022
- First submitted
- 29 Jun 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon Catheters in Peripheral Arteries
- ClinicalTrials.gov ID
- NCT05445258
- Acronym / sponsor ID
- HYPER / InnoCathAB®_01
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Design of the study device will be modified
- Enrolment
- 3 participants (actual)
- Lead sponsor
- InnoRa GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InnoCath AB® Balloon | Experimental | Device: InnoCath AB® hyper-compliant balloon catheterendovascular 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Aneurysms at the site of inflation
- Application directly in the area of large vessel wall injuries with heavy bleeding
- Rutherford classification 5 and 6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InnoCath AB® hyper-compliant balloon catheterendovascular 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® Balloon |
Primary outcome
Safety and tolerance
Time frame: up to 30 days after intervention
Number of events, which are related to the medical device being tested
3 secondary outcomes
Procedural success
Time frame: till the end of the procedure
Handling of the InnoCath AB® hyper-compliant balloon catheter
Time frame: throughout the entirety of the procedure
Device deficiencies of the InnoCath AB® hyper-compliant balloon catheter
Time frame: throughout the entirety of the procedure
Results and safety
The study was stopped early (reason given: Design of the study device will be modified). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Werk, Dr principal investigator
Martin-Luther-Krankenhaus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InnoCath AB® hyper-compliant balloon catheter in people with Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II, run by InnoRa GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Design of the study device will be modified). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerance (time frame: up to 30 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.