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

Recruiting

• Conditions: Coronary Artery Disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12608000373370
• Lead Sponsor: Bioabsorbable Therapuetics, LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified