A Pilot Study With the IDEAL TM Bioabsorbable Coronary Stent Platform Eluting Sirolimus (WHISPER)

A Pilot Study Evaluating the Safety and Performance of the IDEAL TM Bioabsorbable Coronary Stent Platform Eluting Sirolimus for the Treatment of Patients with Coronary Artery Disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000373370

Acronym

WHISPER

Enrollment

Registered

2008-07-31

Start date

2008-03-13

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is being performed to evaluate the safety and performance of the IDEAL Stent for the treatment of patients with cardiovascular disease.

Interventions

The IDEAL TM Coronary Stent is a biodegradable, drug eluting coronary stent that is implanted through a small incision in the groin area using standard interventional technique (as is done for the placement of any coronary stent) for minimally invasive cardiovascular procedures. Patients who present with a lesion amenable to stent placement and meet the protocol's eligibility criteria may be enrolled and undergo placement of one IDEAL stent.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. The patient has documented evidence of ischemic heart disease or a positive functional study. 2. The patient has a single de novo target lesion in a native coronary artery. 4. Target lesion stenosis is greater than 50% and less than 100%.

Exclusion criteria

1. The patient has a restenotic target lesion. 2. The patient has a lesion involving a bifurcation > 2mm in diameter and ostial lesion > 40% stenosis or side branch requiring dilatation. 3. Target vessel contains visible thrombus. 4. The patient has an inability to tolerate, adverse reaction, or contraindication to taking study medications or device materials. 5. The target lesion is a total occlusion. 6. Myocardial Infarction (MI) within 48 hours. 7. The patient has more than one lesion requiring treatment in the target vessel. 8. The patient has one or more non-target lesion requiring treatment.

Outcome results