Healing IIB Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth

Phase 4

Completed

• Conditions: coronary artery lesions; 10011082

• Registration Number: NL-OMON30049
• Lead Sponsor: genae associates

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

-Treatment of 1 or 2 de novo lesions;
-Target lesion(s) is(are) located in a native coronary artery, which can be covered by one single stent of maximum 33 mm;
- Reference vessel diameter min.2.5 and max.3.75 mm by visual estimate;
- Target lesion stenosis is >50% and <100%;
- The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent.

Exclusion Criteria

- A Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes or Troponin levels are less than twice the Upper Normal Limit;
- Documented or suspected liver disease;
- Recipient of heart transplant;
- Known allergies to aspirin, clopidogrel bisulphate and ticlopidine, heparin, or stainless steel;
- Any patient who previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-mouse Antibodies (HAMA).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint<br /><br>The primary endpoint of this study is in-stent late loss at 6 months by<br /><br>Quantitative Coronary Angiography (QCA).</p><br>