Vascular DiseasesNCT05497440
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 United States.
Trial summary
The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice. 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to 7 Oct 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
- A participant will be eligible to participate in the study if all of the following apply:
- 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
- The following subjects will be excluded from the study if any of the following criteria are met:
- 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.
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- The use of antiplatelet or anticoagulant therapy is contraindicated.
- 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 Contrast Balloon Catheter 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.
The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
Read the detailed description
The All'InCath Contrast Balloon Catheter 035M Balloon Dilatation Catheter has received 510(k) clearance for Percutaneous Transluminal Angioplasty in the peripheral vasculature, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, and angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media (K191275).
The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter, including device-related perioperative adverse events, vascular patency, visualization of the target area, duration of intervention, level of radiation exposure, dose of contrast agent, post-procedural adverse events and physician's feedback, 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
All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.
| Study group | Role | What they receive |
|---|---|---|
| All'InCath CBC 035M Balloon Dilatation Catheter | Experimental | All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography. 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.
Periprocedural Serious adverse events
Freedom from device related periprocedural adverse events and complications during PTA procedure (e.g., loss of guidewire, misdirection of catheter, vessel wall perforation or dissection requiring treatment).
Measured: During procedure
Vascular patency
Vascular patency immediately post-procedure with adequate capability to ensure injection medium contrast into the vessel with a good visualization of the targeted area.
Measured: immediately post-procedure
Secondary outcomes (5)
Duration of the intervention (PTA)
Performance of the All'InCath Contrast Balloon Catheter 035M
Measured: Time of the procedure
Level of radiation exposure during PTA (mGy).
Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M
Measured: During procedure
Dose of contrast agent injected at the targeted location (mL).
Safety and performance of the All'InCath Contrast Balloon Catheter 035M
Measured: During procedure
Investigator's feedback
Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M
Measured: During procedure
Major adverse events during hospitalization until discharge
Safety of the All'InCath Contrast Balloon Catheter 035M
Measured: before hospital discharge or 24hours after the index-procedure which ever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start7 Jul 2022
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Why it stopped: Not enough product.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NexStep Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rabih Chaer, Principal investigator, UPMC 200 Lothrop Street Pittsburgh, PA 15213
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497440
- Sponsor's protocol ID
- CSP-0003
- Status last verified
- Jan 2025
- First submitted
- 8 Aug 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Information about subjects will be considered confidential. Subject's identification must be anonymized at the site by the Investigator or designee, when completing the case report form (CRF), study-related worksheets, preparation of clinical reports or the preparation of subject medical records. Only authorized personnel might have access to these confidential files. Every reasonable effort will be made to protect the confidentiality of the subjects throughout the study.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the All'InCath Contrast Balloon Catheter 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.
- ClinicalTrials.gov ID
- NCT05497440
- Acronym / sponsor ID
- CSP-0003
- Conditions
- Vascular Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough product.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NexStep MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 11 Aug 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.
The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
Detailed description
The All'InCath Contrast Balloon Catheter 035M Balloon Dilatation Catheter has received 510(k) clearance for Percutaneous Transluminal Angioplasty in the peripheral vasculature, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, and angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media (K191275).
The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter, including device-related perioperative adverse events, vascular patency, visualization of the target area, duration of intervention, level of radiation exposure, dose of contrast agent, post-procedural adverse events and physician's feedback, 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 CatheterAll participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A participant will be eligible to participate in the study if all of the following apply:
- Ability to provide Informed Consent
- 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 (14 listed)
- The following subjects will be excluded from the study if any of the following criteria are met:
- 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.
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 CatheterAll participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography. | Device | All'InCath CBC 035M Balloon Dilatation Catheter |
Primary outcome
Periprocedural Serious adverse events
Time frame: During procedure
Freedom from device related periprocedural adverse events and complications during PTA procedure (e.g., loss of guidewire, misdirection of catheter, vessel wall perforation or dissection requiring treatment).
Vascular patency
Time frame: immediately post-procedure
Vascular patency immediately post-procedure with adequate capability to ensure injection medium contrast into the vessel with a good visualization of the targeted area.
5 secondary outcomes
Duration of the intervention (PTA)
Time frame: Time of the procedure
Level of radiation exposure during PTA (mGy).
Time frame: During procedure
Dose of contrast agent injected at the targeted location (mL).
Time frame: During procedure
Investigator's feedback
Time frame: During procedure
Major adverse events during hospitalization until discharge
Time frame: before hospital discharge or 24hours after the index-procedure which ever occurs first
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No. Information about subjects will be considered confidential. Subject's identification must be anonymized at the site by the Investigator or designee, when completing the case report form (CRF), study-related worksheets, preparation of clinical reports or the preparation of subject medical records. Only authorized personnel might have access to these confidential files. Every reasonable effort will be made to protect the confidentiality of the subjects throughout the study.
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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.
Rabih Chaer principal investigator
UPMC 200 Lothrop Street Pittsburgh, PA 15213
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 United States.
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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 31 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Periprocedural Serious adverse events (time frame: During 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 31 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.