Study to evaluate the safety and feasibility of the STENTYS Balloon Delivery System (STENTYS-BDS).

Completed

• Conditions: Coronary artery stenosis; coronary atherosclerosis; 10007593; 10011082

• Registration Number: NL-OMON41177
• Lead Sponsor: STENTYS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Age between 18 years and 80 years.
2. Patients with an indication to receive a STENTYS-SES according to the IFU.*
3. Signed Informed Consent.
4. Reference Vessel Diameter >2.5mm and <6.0mm by visual assessment.
5. Target lesion *25mm in length by visual estimate.;* Inclusion of STEMI patients allowed if sufficient time available for demanding written informed consent before stent placement.

Exclusion Criteria

Clinical:
1. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
2. Currently enrolled in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
3. Patients on anticoagulation therapy (Coumadin).
4. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, sirolimus, contrast material.
5. Known thrombocytopenia (PLT<100,000/mm3).
6. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy.
7. Cardiogenic shock.
8. Major planned surgery that requires discontinuation of dual antiplatelet therapy.
9. Co-morbid condition(s) that could limit the subject*s ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study ;Angiographic:
10. Severe tortuous, calcified or angulated coronary anatomy of the study vessel.
11. Myocardial infarction due to stent thrombosis, or infarct lesion at a previously stented coronary artery.
12. Unprotected left main coronary artery stenosis >30% by visual assessment
13. Staged procedure is planned within 30 days*
14. Target lesion is a chronic total occlusion
15. Perforated vessels evidenced by extravagation of contrast media;* Treatment of other lesions during the same procedure in target- and non-target vessel is allowed

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Technical success, defined as the ability to cross with the device and deploy<br /><br>the stent as intended at the target lesion.</p><br>