Evaluation with OFDI of strut coverage of Terumo new Drug Eluting Stent TCD-10023 with biodegradable polymer at 1, 2 and 3 months.
- Conditions
- Coronary artery disease and arterial stent strut coverage - narrowings of coronary arteries and tissue growth (enodthelium) inside the stent10011082
- Registration Number
- NL-OMON38569
- Lead Sponsor
- Terumo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
1. Patient is at least 18 years old;
2. Patients is a suitable candidate for PCI;
3. Patient has multi-vessel disease with >=2 de-novo lesions in native coronary arteries suitable for treatment with TCD-10023 DES;
4. Target lesions are suitable for OFDI examination;
5. Patient requires staged procedure between 3-5 weeks after baseline procedure, according to investigator*s judgement;
6. Target vessel reference diameter is between 2.5 - 4.0 mm (visual assessment);
7. Patient has provided written informed consent;
8. Patient is affiliated to social security or equivalent system (France only).
1. Patient has known allergy to sirolimus, cobalt, chromium, nickel, or contrast agent (that cannot be adequately premedicated);
2. Patient is not a suitable candidate for use of DAPT because of active or recent bleedings or for use of vitamin K antagonist, like warfarin, dabigatran, rivaroxaban or acenocoumarol;
3. Patient is presenting with STEMI at baseline procedure;
4. Patient has Killip class > 1 at admission;
5. Patient is in cardiogenic shock;
6. Patient is a female of childbearing potential;
7. Patient has life expectancy of less then 1 year;
8. Patient is expected to undergo major surgery within 3 months;
9. Patient has Left Main disease >= 50%;
10. Target lesion at bifurcation requiring 2 stents technique;
11. Target lesions are severely calcified;
12. Target lesion is aorta-ostially located (within 3 mm of vessel origin);
13. Patient has renal failure defined as estimated Glomerular Filtration Rate (eGFR) <50 mL/min/1.73m²;
14. Target lesions require preparation other than balloon pre-dilatation;
15. Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials;
16. In the Investigator*s opinion patient has (a) co-morbid condition(s) that could limit the patient*s ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study;
17. Patient is under judicial protection (France only).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is OFDI assessed percent stent strut coverage at 3 months<br /><br>post procedure.<br /><br>Hypothesis: <20% uncovered struts at 3 months post procedure<br /><br>NOTE: the Primary endpoint will be assessed for all single stent lesions.</p><br>
- Secondary Outcome Measures
Name Time Method