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

NCT05497440 | Withdrawn FDA Device

• 1 other identifier: CSP-0003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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).

  During procedure

• 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.

  immediately post-procedure

Secondary Outcomes (5)

• Duration of the intervention (PTA)

  Time of the procedure

• Level of radiation exposure during PTA (mGy).

  During procedure

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

  During procedure

• Investigator's feedback

  During procedure

• Major adverse events during hospitalization until discharge

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

Study Arms (1)

All'InCath CBC 035M Balloon Dilatation Catheter

EXPERIMENTAL

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

Device: All'InCath CBC 035M Balloon Dilatation Catheter

Interventions

All'InCath CBC 035M Balloon Dilatation Catheter DEVICE

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

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:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NexStep Medical: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Rabih Chaer

  UPMC 200 Lothrop Street Pittsburgh, PA 15213

  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: August 8, 2022
• First Posted: August 11, 2022
• Study Start: July 7, 2022
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)