Vascular DiseasesCBC035MNCT05153421
Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.
A study testing All'InCath CBC 035M Balloon Dilatation Catheter in people with Vascular Diseases, run by NexStep Medical at 1 site in France.
Trial summary
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- All'InCath CBC 035M Balloon Dilatation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2021to 6 Dec 2024
- 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
- Ability to provide Informed Consent
- Can also be executed by the legal designated representative or the witness
- As per the Principal Investigator's practices as per standard of care, the subject is indicated for PTA in the peripheral vasculature, including iliac, femoral, popliteal, and renal arteries, and any treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Male or female >18 years old.
- Life expectancy >1 year
Who cannot join
- Unstable coronary artery disease or any other uncontrolled comorbidity.
- Myocardial infarction or stroke within two (2) months before baseline evaluation.
- Previous peripheral bypass or procedure that includes the target vessel.
- Known, untreated allergy or other contraindications to contrast agents or medications used during or after PTA.
- Non-correctable bleeding diathesis, platelet dysfunction, thrombocytopenia, or any other known coagulopathy.
- The use of antiplatelet or anticoagulant therapy is contraindicated.
Show all 13Show fewer
- Any planned major surgical or interventional procedure within 30 days after the study procedure.
- Females who are breast-feeding or child-bearing potential and not using a medically reliable method of contraception (as defined below) for the entire study duration:
- medically reliable contraception defined as: oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or those not using another method deemed by the Investigator to be sufficiently reliable.
- subjects who are surgically sterilized / hysterectomized or post-menopausal for longer than two (2) years are not considered childbearing potential.
- Positive pregnancy test result in women of child bearing potential or is breast-feeding.
- Incapacitated individuals and those with psychiatric disorders that could interfere with the provision of informed consent, completion of tests, therapy, follow-up or general study compliance.
- Participation in another study with investigational drug or device within the 30 days preceding and during the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the All'InCath CBC 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities.
Read the detailed description
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
- Conditions
- Vascular Diseases
- Being tested
- All'InCath CBC 035M Balloon Dilatation Catheter
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All'InCath CBC 035M Balloon Dilatation CatheterDevice
Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.
| Study group | Role | What they receive |
|---|---|---|
| All'InCath CBC 035M Balloon Dilatation Catheter | Experimental | Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter. Receives: Device: All'InCath CBC 035M Balloon Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the All'InCath Contrast Balloon Catheter 035M
Periprocedural Serious Adverse Events
Measured: immediately post-procedure
Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M
Vascular patency
Measured: immediately post-procedure
Secondary outcomes (5)
Performance of the All'InCath Contrast Balloon Catheter 035M
Duration of the PTA procedure.
Measured: Time of Procedure
Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M
Investigator opinion
Measured: During Procedure
Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M
Level of radiation exposure during the PTA (mGy).
Measured: During Procedure
Safety and performance of the All'InCath Contrast Balloon Catheter 035M
Dose of injected contrast medium at the targeted location (mL)
Measured: During Procedure
Safety of the All'InCath Contrast Balloon Catheter 035M
Post procedural adverse events
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start6 May 2021
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Why it stopped: As part of the new regulatory requirements in Europe and in accordance with the MDR regulation set to take effect on January 1, 2025, NexStep Medical is compelled to prematurely terminate its ongoing clinical study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NexStep Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabien Thaveau, MD, PhD, Principal investigator, Geprovas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153421
- Sponsor's protocol ID
- CSP-0001
- Acronym
- CBC035M
- Status last verified
- Jan 2025
- First submitted
- 20 Oct 2021
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the All'InCath CBC 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.
- ClinicalTrials.gov ID
- NCT05153421
- Acronym / sponsor ID
- CBC035M / CSP-0001
- Conditions
- Vascular Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As part of the new regulatory requirements in Europe and in accordance with the MDR regulation set to take effect on January 1, 2025, NexStep Medical is compelled to prematurely terminate its ongoing clinical study.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NexStep MedicalIndustry (pharma, biotech, devices)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 10 Dec 2021 (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.
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities.
Detailed description
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All'InCath CBC 035M Balloon Dilatation Catheter | Experimental | Device: All'InCath CBC 035M Balloon Dilatation CatheterPeripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide Informed Consent
- Can also be executed by the legal designated representative or the witness
- As per the Principal Investigator's practices as per standard of care, the subject is indicated for PTA in the peripheral vasculature, including iliac, femoral, popliteal, and renal arteries, and any treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Male or female >18 years old.
- Life expectancy >1 year
Key exclusion criteria (13 listed)
- Unstable coronary artery disease or any other uncontrolled comorbidity.
- Myocardial infarction or stroke within two (2) months before baseline evaluation.
- Previous peripheral bypass or procedure that includes the target vessel.
- Known, untreated allergy or other contraindications to contrast agents or medications used during or after PTA.
- Non-correctable bleeding diathesis, platelet dysfunction, thrombocytopenia, or any other known coagulopathy.
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 |
|---|---|---|
| All'InCath CBC 035M Balloon Dilatation CatheterPeripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter. | Device | All'InCath CBC 035M Balloon Dilatation Catheter |
Primary outcome
Safety of the All'InCath Contrast Balloon Catheter 035M
Time frame: immediately post-procedure
Periprocedural Serious Adverse Events
Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M
Time frame: immediately post-procedure
Vascular patency
5 secondary outcomes
Performance of the All'InCath Contrast Balloon Catheter 035M
Time frame: Time of Procedure
Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M
Time frame: During Procedure
Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M
Time frame: During Procedure
Safety and performance of the All'InCath Contrast Balloon Catheter 035M
Time frame: During Procedure
Safety of the All'InCath Contrast Balloon Catheter 035M
Time frame: 3 days
Results and safety
The study was stopped early (reason given: As part of the new regulatory requirements in Europe and in accordance with the MDR regulation set to take effect on January 1, 2025, NexStep Medical is compelled to prematurely terminate its ongoing clinical study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Vascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Fabien Thaveau, MD, PhD principal investigator
Geprovas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All'InCath CBC 035M Balloon Dilatation Catheter in people with Vascular Diseases, run by NexStep Medical at 1 site in France.
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 13 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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: As part of the new regulatory requirements in Europe and in accordance with the MDR regulation set to take effect on January 1, 2025, NexStep Medical is compelled to prematurely terminate its ongoing clinical study.). 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 of the All'InCath Contrast Balloon Catheter 035M (time frame: immediately post-procedure). The study lists 2 primary outcomes in all. 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 28 Jan 2025.