Clinical trial NCT03301246: Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease
Official title: Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Heart Disease, Ischemic
Coronary Stenosis
Lead sponsor: Eminence Clinical Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: BrosMed Medical Co., Ltd
First posted: 2017-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedure Success
timeFrame: Day 1 - Index Procedure
Secondary outcomes:
measure: Anticipated Adverse Events
timeFrame: Day 1 - Index Procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jasvinder Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: