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Balloon Catheter

Coronary Dilatation Catheter for Heart Disease

N/A

Recruiting

Led By David Kandzari, MD

Research Sponsored by OrbusNeich

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is ≥ 18 years of age

Subject must have at least one de novo or restenotic lesion in native coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow grade of 0 or 1 and is estimated to be at least 3 months in duration by clinical, angiographic, or electrocardiographic criteria

Must not have

Coronary artery spasm of the target vessel in the absence of a significant stenosis

By visual estimation, target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.25 mm in diameter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post-procedure or hospital discharge, whichever comes first

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the safety and performance of a specific coronary dilatation catheter in treating Chronic Total Occlusion (CTO) lesions during a heart procedure. They plan to enroll 170 participants

Who is the study for?

This trial is for adults with certain heart conditions like chronic total occlusion and coronary artery disease. Participants must have one or two lesions in their arteries, be over 18, give written consent, not join other studies that conflict with this one during hospitalization, and are scheduled for a stent placement.

What is being tested?

The Sapphire 3 Coronary Dilatation Catheter is being tested to see how safe it is and how well it works when used to open up blocked arteries in the heart before placing a stent. This study will observe patients after they undergo this procedure.

What are the potential side effects?

While specific side effects aren't listed here, typical risks of catheter use include bleeding at the insertion site, infection, blood vessel damage, irregular heartbeats (arrhythmias), or allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a blocked artery in my heart that has been present for at least 3 months.

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I have up to two blockages in my heart's arteries.

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I have heart disease affecting one or two arteries and need a procedure to open these.

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My target lesion will be treated with a stent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart's artery spasms without major blockage.

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My heart condition requires multiple stents due to a blockage at a branch point.

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I have not had a stomach ulcer or GI bleeding in the last 6 months.

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I have a significant blockage in the main artery of my heart.

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I am allergic to aspirin, heparin, certain blood thinners, or contrast dyes and cannot be pre-medicated for it.

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My heart's blood vessels have a significant clot.

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I plan to, or have already, used a non-approved method before the study treatment.

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I need treatment for more than two lesions.

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I have a working bypass graft from previous heart surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ peri-procedural

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~peri-procedural

This trial's timeline: 3 weeks for screening, Varies for treatment, and peri-procedural for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Device Procedural Success

Secondary study objectives

Number of Deaths (Cardiac and Non-Cardiac)

Number of Participants That Had Improvement in the Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (independently measured by the Angiographic Core Lab using QCA)

Number of Participants With Absence of Sapphire 3 Study Balloon Rupture

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