Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2020-05-08

Brief Summary

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This is a prospective, non-randomized, open label, multi-center study including 60 patients with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions enrolled and treated in this investigational device study.

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Detailed Description

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Patients who require initial pre-dilatation using the study device, and then undergo definitive therapy using additional PTCA catheters and stents, according to standard of care will be enrolled in this study.

A maximum of 60 subjects with native coronary artery lesions or occlusions will be treated using the Artimes pro Balloon Dilatation Catheters in a 3:1 ratio using the 1.0mm and 1.25mm dilatation catheters for pre-dilatation and will complete the study within the U.S. This equals 45 patients treated using the 1.0mm dilatation catheter, and 15 patients treated with the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated.

Conditions

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Coronary Artery Disease Heart Disease, Ischemic Coronary Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

45 patients will be treated using the 1.0mm dilatation catheter and 15 patients treated with the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated. Patients may be consented, enrolled and treated until the sample size is reached, with n=60 completing the study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Artimes Pro Low Profile Dilatation Catheter

Subjects who require initial pre-dilatation using the study device, and then undergo definitive therapy using additional PTCA catheters and stents, according to standard of care will be enrolled in this study.

Group Type EXPERIMENTAL

Artimes Pro Low Profile Dilatation Catheter

Intervention Type DEVICE

Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.

Interventions

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Artimes Pro Low Profile Dilatation Catheter

Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age;
* Willing and able to provide informed consent;
* Willing and able to meet all study requirements;
* Patients with symptomatic ischemic heart disease due to stenotic lesions or occlusions in coronary arteries that are amenable to percutaneous coronary interventions;
* Patients who tolerate DAPT

Exclusion Criteria

* A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated;
* LVEF \< 30%;
* Evidence of an acute myocardial infarction within 72 hours of the intended index procedure;
* Planned treatment of unprotected left main disease;
* History of cerebral vascular accident (CVA) within 6 months prior to consideration for this study;
* Transient ischemic attack (TIA) within 6 months prior to consideration for this study;
* Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months prior to consideration for this study;
* History of bleeding diathesis or coagulopathy;
* Refuses blood transfusions;
* Any general contraindication to revascularization procedures;
* Pregnant or lactating;
* In the judgement of the investigator, patient is not a suitable candidate for this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No