The objective of this study is to evaluate whether two different stent technologies (a self-expandable stent and a balloon-expandable stent) may be associated with different stent strut apposition and a variety of stent strut coverage with…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of stent strut malapposistie at 9 months, assessed by OCT.
Secondary outcome
OCT endpoint at 4 months:
1. Percentage of stent strut malapposistie
OCT endpoints at 4 or 9 months:
2. Percentage of bare stent struts
3. Healing Score
4. Mean Flow area / volume. (Average flow surface / volume)
5. Intraluminal defect area / volume. (Defective intraluminal surface / volume)
6. Mean stent area / volume. (Mean stent area / volume)
7. Incomplete Stent Apposition (ISA) area / volume (Incomplete stent apposition)
8. Tissue prolapse area / volume. (Surface tissue by the struts / volume)
Clinical secondary endpoints:
9. Procedure success: <30% residual stenosis of the target lesion and no MACE
during hospitalization (cardiac death, bypass surgery (CABG) or
revascularization (TLR, clinically driven) and non-fatal myocardial infarction).
10. MACE at 1, 4 / 9 and 12 months
11. Target Vessel Failure (TVF), defined as cardiac death, reinfarction in the
area of **the infarct-related vessel (Q wave and non Q-wave according to ARC
definition), or clinically driven revascularization of the vessel - and its
individual components - for dismissal , 1, 4 / 9 and 12 months.
12. Any death, any myocardial infarction, target vessel revascularisation.
13. Stent thrombosis by ARC definition at discharge, at 1, 4 / 9 and 12 months.
14. All other SAEs at discharge, 1, 4 / 9 and 12 months.
Angiographic secondary endpoints:
15. In-stent and in-segment (5 mm proximal and distal margins of the stent)
Minimum Lumen Diameter (MLD) at baseline and at 4 / 9 months.
16. In-stent and in-segment (5 mm proximal and distal margin of the stent)
Percent diameter stenosis (% DS) at baseline and 4 / 9 months
17. Acute Gain (mm) post-stent procedure.
18. In-stent and in-segment (late) lumen loss at 4 / 9 months.
19. In-stent and in-segment binary restenosis (diameter stenosis >= 50%) on 4 /
9 months.
20. TIMI flow pre-and post-procedure and at follow-up.
21. TIMI (corrected) frame count post procedure.
22. Myocardial blush grade post-procedure.
ECG endpoint:
23. ST segment elevation resolution:% reduction of ST-segment elevation 90 ± 30
minutes after the procedure.
IMR endpoint:
24. Index of microvascular resistance (IMR Index of micro-vascular resistance)
post procedure (selected sites)
25. Percentage of patients with an IMR <= 32.
Background summary
Recently a new type of stent has been developed, the self-expandable
Sirlimus-eluting Stentys-Stent. For placement of the stent, It is not necessary
to use a balloon, thus reducing the chance of damaging the vessel wall, which
is a risk when stents are placed using a balloon .. The stent slowly unfolds
itself in the placement and settles against the wall to keep it open.
Study objective
The objective of this study is to evaluate whether two different stent
technologies (a self-expandable stent and a balloon-expandable stent) may be
associated with different stent strut apposition and a variety of stent strut
coverage with endothelial tissue, evaluated by intra-coronary OCT 4 or 9 months
(depending on randomization) post-stent implantation.
Study design
This is a prospective, multicenter, randomized study in which 150 patients will
participate in about 20 European hospitals
Intervention
Two treatment groups will be assessed:
- STENTYS DES (S) self-expandable stent (SE) stent
- DES balloon-expandable stent (BE) Zotarolimus-eluting (Medtronic Resolute)
The antiplatelet therapy in both cohorts will consist of at least 100 mg of
aspirin indefinitely. All patients receive clopidogrel or prasugrel 75 mg of
5-10mg daily for at least 12 months post-stent implantation.
Study burden and risks
risks under the risks of percutaneous treatment of acute myocardial infarction.
The load consists of a re-catheterisation (+standard risks as described in the
brochure of the Dutch Heart Foundation)
A clinic visit
4 phone consultations
Rue Choiseul 25
Parijs 75002
FR
Rue Choiseul 25
Parijs 75002
FR
Listed location countries
Age
Inclusion criteria
clinical:
1. Aged between 18 and 80 years.
2. Patients with ST-elevation myocardial infarction in the ambulance or in the cathlab >= 0.2 mV of ST-segment elevation in at least two consecutive leads, <12 hours after the onset of symptoms for >= 20 min
3. Target lesion is a de novo lesion
4. Signed authorization for informed patients
Angiography:
5. Diameter of the vessel is between 2.5 and 4.0mm corresponding to the available STENTYS and Resolute stent sizes (by visual assessment).
6. Target lesion <= 25mm in length (visual assessment).
Exclusion criteria
clinical:
1. Pregnant women or nursing woman or woman of childbearing age without adequate contraception
2. Participation in another clinical study that the primary endpoint has not yet reached, or which interferes with the current study endpoints.
3. Coronary intervention or cardiac or major surgery <30 days ago.
4. Target vessel is a blood vessel that has a bypass.
5. Patient using Coumadin
6. Known hypersensitivity to aspirin, clopidogrel, heparin, stainless steel, sirolimus, Zotarolimus, contrast material.
7. Known thrombocytopenia (PLT <100,000 / mm3).
8. Active bleeding or coagulopathy or chronic anticoagulant therapy
9. Cardiogenic shock
10. Elective surgery and that discontinuation of dual antiplatelet therapy (DAPT) therapy is required.
11. Significant comorbidity which have the probability of non-compliance to clinical follow-up or affect the scientific integrity of the research (as judged by the investigator).
12. Left ventricular ejection fraction (LVEF) <30%.
13. Stroke or TIA within the last 6 months.;Angiography:
14. Severely tortuous, calcified or angulated coronary anatomy of the target vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complications from the placement of an OCT catheter.
15. Myocardial infarction due to stent thrombosis or infarction lesion in a previously stented coronary artery.
16. Unprotected left main stenosis> 30% (visual assessment)
17. Patients with significant lesions in two coronary arteries that require additional treatment within 30 days.
18. Patients with significant lesions in all three coronary arteries
19. Target lesion is a chronic total occlusion
20. Perforated drum, demonstrated by leakage of contrast.
21. Aneurysmal dilation, proximal or distal to the lesion
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39177.078.12 |