Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty. (CBC035M)

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases
• Intervention / Treatment: Device: All'InCath CBC 035M Balloon Dilatation Catheter

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Urbain; Phone Number: 0033 611724585; Email: purbain@nexstepmedical.com

Study Locations

• France
  • Strasbourg, France, 67000
    • Recruiting
    • Hopitaux Universitaires de Strasbourg
    • Contact: Fabien Thaveau, MD, PhD; Phone Number: 0033 369550927; Email: fabien.thaveau@chru-strasbourg.fr
    • Principal Investigator: Fabien Thaveau, MD, PhD
    • Sub-Investigator: Laurence Bruyns, MD
    • Sub-Investigator: Benjamin Del Tatto, MD
    • Sub-Investigator: Anne Lejay, MD, PhD
    • Sub-Investigator: Yannick Georg, MD, PhD

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:

• 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the All'InCath Contrast Balloon Catheter 035M	Periprocedural Serious Adverse Events	immediately post-procedure
Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M	Vascular patency	immediately post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the All'InCath Contrast Balloon Catheter 035M	Duration of the PTA procedure.	Time of Procedure
Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M	Investigator opinion	During Procedure
Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M	Level of radiation exposure during the PTA (mGy).	During Procedure
Safety and performance of the All'InCath Contrast Balloon Catheter 035M	Dose of injected contrast medium at the targeted location (mL)	During Procedure
Safety of the All'InCath Contrast Balloon Catheter 035M	Post procedural adverse events	3 days

Collaborators and Investigators

• Sponsor: NexStep Medical
• Investigators: Principal Investigator: Fabien Thaveau, MD, PhD, GEPROVAS

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: CSP-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes