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

NCT05153421 | Terminated FDA Device

• 1 other identifier: CSP-0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Performance of the All'InCath Contrast Balloon Catheter 035M

  Time of Procedure

• Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M

  During Procedure

• Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M

  During Procedure

• Safety and performance of the All'InCath Contrast Balloon Catheter 035M

  During Procedure

• Safety of the All'InCath Contrast Balloon Catheter 035M

  3 days

Study Arms (1)

All'InCath CBC 035M Balloon Dilatation Catheter

EXPERIMENTAL

Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.

Device: All'InCath CBC 035M Balloon Dilatation Catheter

Interventions

All'InCath CBC 035M Balloon Dilatation Catheter DEVICE

Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.

All'InCath CBC 035M Balloon Dilatation Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NexStep Medical: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Fabien Thaveau, MD, PhD

  Geprovas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: December 10, 2021
• Study Start: May 6, 2021
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)