Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.

Vascular Diseases Clinical Trial

— CBC035M  

Official title:

Clinical Evaluation of the All'InCath CBC 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05153421
• Other study ID #: CSP-0001
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: May 2023

Study information

• Verified date: August 2022
• Source: NexStep Medical
• Contact: Philippe Urbain
• Phone: 611724585
• Email: purbain[@]nexstepmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• 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.

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• All'InCath CBC 035M Balloon Dilatation Catheter
Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
NexStep Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the All'InCath Contrast Balloon Catheter 035M	Periprocedural Serious Adverse Events	immediately post-procedure
Primary	Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M	Vascular patency	immediately post-procedure
Secondary	Performance of the All'InCath Contrast Balloon Catheter 035M	Duration of the PTA procedure.	Time of Procedure
Secondary	Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M	Investigator opinion	During Procedure
Secondary	Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M	Level of radiation exposure during the PTA (mGy).	During Procedure
Secondary	Safety and performance of the All'InCath Contrast Balloon Catheter 035M	Dose of injected contrast medium at the targeted location (mL)	During Procedure
Secondary	Safety of the All'InCath Contrast Balloon Catheter 035M	Post procedural adverse events	3 days