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

Primary Purpose

Vascular Diseases

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

All'InCath CBC 035M Balloon Dilatation Catheter

About this trial

This is an interventional treatment trial for Vascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion criteria

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All'InCath CBC 035M Balloon Dilatation Catheter

Arm Description

All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

Duration of the intervention (PTA)

Performance of the All'InCath Contrast Balloon Catheter 035M

Level of radiation exposure during PTA (mGy).

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

Dose of contrast agent injected at the targeted location (mL).

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

Investigator's feedback

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

Major adverse events during hospitalization until discharge

Safety of the All'InCath Contrast Balloon Catheter 035M

Full Information

NCT ID

NCT05497440

First Posted

August 8, 2022

Last Updated

August 9, 2022

Sponsor

NexStep Medical

1. Study Identification

Unique Protocol Identification Number

NCT05497440

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2022 (Anticipated)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NexStep Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vascular Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All'InCath CBC 035M Balloon Dilatation Catheter

Arm Type

Experimental

Arm Description

All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.

Intervention Type

Device

Intervention Name(s)

All'InCath CBC 035M Balloon Dilatation Catheter

Intervention Description

All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.

Primary Outcome Measure Information:

Title

Periprocedural Serious adverse events

Description

Time Frame

During procedure

Title

Vascular patency

Description

Vascular patency immediately post-procedure with adequate capability to ensure injection medium contrast into the vessel with a good visualization of the targeted area.

Time Frame

immediately post-procedure

Secondary Outcome Measure Information:

Title

Duration of the intervention (PTA)

Description

Performance of the All'InCath Contrast Balloon Catheter 035M

Time Frame

Time of the procedure

Title

Level of radiation exposure during PTA (mGy).

Description

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

Time Frame

During procedure

Title

Dose of contrast agent injected at the targeted location (mL).

Description

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

Time Frame

During procedure

Title

Investigator's feedback

Description

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

Time Frame

During procedure

Title

Major adverse events during hospitalization until discharge

Description

Safety of the All'InCath Contrast Balloon Catheter 035M

Time Frame

before hospital discharge or 24hours after the index-procedure which ever occurs first

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion criteria 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Philippe Urbain

Phone

+33611724585

purbain@nexstepmedical.com

First Name & Middle Initial & Last Name or Official Title & Degree

Diane Marceau

Phone

5819987754

dmarceau@nexstepmedical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rabih Chaer

Organizational Affiliation

UPMC 200 Lothrop Street Pittsburgh, PA 15213

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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.

Learn more about this trial

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

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