CompletedPhase 1ACTRN12611001131943

Drug-Eluting Stent Study Evaluating a New Technology in Patients with Symptomatic Ischemic Heart Disease due to Coronary Artery Blockage

Evaluating the Svelte Drug Eluting Stent-on-a-Wire (DESOAW) in Patients with Symptomatic Ischemic Heart Disease due to Coronary Artery Blockage


Sponsor

Svelte Medical Systems, Inc.

Enrollment

30 participants

Start Date

Nov 2, 2011

Study Type

Interventional

Conditions

Summary

The objective of this trial is to assess the safety and clinical performance of the novel Svelte DESOAW Coronary Stent System with fully bioerodable drug carrier eluting the well-studied drug compound sirolimus in patients with single de novo coronary artery lesions.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study evaluates a new drug-eluting coronary stent in patients with symptomatic ischemic heart disease caused by blocked coronary arteries. Participants must be at least 18, eligible for stent placement, and have clinical evidence of heart disease with a target blockage of 50-100% in a vessel 2.5 to 3.5mm wide. People with recent heart attacks (within 72 hours), total vessel occlusion, or who need blood-thinning medication like warfarin are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The percutaneous revascularization of native coronary arteries exhibiting stenotic lesion(s) using a novel sirolimus-eluting cobalt chromium stent with bioerodable drug carrier delivered via fixed-wir

The percutaneous revascularization of native coronary arteries exhibiting stenotic lesion(s) using a novel sirolimus-eluting cobalt chromium stent with bioerodable drug carrier delivered via fixed-wire catheter system is similar to current stenting procedures. Depending on difficulty of lesion treatment, procedures, typcially under conscious sedation, take between 30 and 90 minutes and are conducted in the cardiology cath lab. A small puncture in the groin or arm provides arterial access to place a stent in the heart using x-ray fluoroscopy for visualization during the procedure. Ususally this is a one-time procedure; however, some patients experience re-clogging of the target artery and have to return for reinitervention.


Locations(3)

Auckland, New Zealand

Christchurch, New Zealand

Wellington, New Zealand

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ACTRN12611001131943


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