Back to resultsEvaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty. (CBC035M)
Primary Purpose
Vascular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
All'InCath CBC 035M Balloon Dilatation Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Diseases
Eligibility Criteria
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.
Sites / Locations
- Hôpitaux Universitaires de StrasbourgRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All'InCath CBC 035M Balloon Dilatation Catheter
Arm Description
Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.
Outcomes
Primary Outcome Measures
Safety of the All'InCath Contrast Balloon Catheter 035M
Periprocedural Serious Adverse Events
Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M
Vascular patency
Secondary Outcome Measures
Performance of the All'InCath Contrast Balloon Catheter 035M
Duration of the PTA procedure.
Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M
Investigator opinion
Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M
Level of radiation exposure during the PTA (mGy).
Safety and performance of the All'InCath Contrast Balloon Catheter 035M
Dose of injected contrast medium at the targeted location (mL)
Safety of the All'InCath Contrast Balloon Catheter 035M
Post procedural adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05153421
Brief Title
Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.
Acronym
CBC035M
Official Title
Clinical Evaluation of the All'InCath CBC 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
May 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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
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
Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.
Intervention Type
Device
Intervention Name(s)
All'InCath CBC 035M Balloon Dilatation Catheter
Intervention Description
Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.
Primary Outcome Measure Information:
Title
Safety of the All'InCath Contrast Balloon Catheter 035M
Description
Periprocedural Serious Adverse Events
Time Frame
immediately post-procedure
Title
Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M
Description
Vascular patency
Time Frame
immediately post-procedure
Secondary Outcome Measure Information:
Title
Performance of the All'InCath Contrast Balloon Catheter 035M
Description
Duration of the PTA procedure.
Time Frame
Time of Procedure
Title
Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M
Description
Investigator opinion
Time Frame
During Procedure
Title
Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M
Description
Level of radiation exposure during the PTA (mGy).
Time Frame
During Procedure
Title
Safety and performance of the All'InCath Contrast Balloon Catheter 035M
Description
Dose of injected contrast medium at the targeted location (mL)
Time Frame
During Procedure
Title
Safety of the All'InCath Contrast Balloon Catheter 035M
Description
Post procedural adverse events
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Urbain
Phone
611724585
Ext
0033
Email
purbain@nexstepmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Marceau
Phone
5819987754
Email
dmarceau@nexstepmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien Thaveau, MD, PhD
Organizational Affiliation
Geprovas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien Thaveau, MD, PhD
Phone
369550927
Ext
0033
Email
fabien.thaveau@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Fabien Thaveau, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nabil Chakfe, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laurence Bruyns, MD
First Name & Middle Initial & Last Name & Degree
Benjamin Del Tatto, MD
First Name & Middle Initial & Last Name & Degree
Anne Lejay, MD, PhD
First Name & Middle Initial & Last Name & Degree
Yannick Georg, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.
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