The primary objective of this study is to determine the feasibility and safety of the Genous Bio-engineered R stent in the treatment of patients presenting with acute myocardial infarction with ST segment elevation within 12 hours of symptoms onset…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Early stent thrombosis at 30 days post-procedure.
Secondary outcome
· Device, lesion, angiographic and procedure success
· Clinically-driven Target Lesion Revascularization (TLR) and Target Vessel
Revascularization (TVR) at 6 and 12 months
· Major Adverse Cardiac Events (MACE) at 30 days, 6 and 12 months
· Stent thrombosis at 6 months and 12 months (include early and late, probable
and
definite).
· Late stent thrombosis (definite and probable).
· In-stent and in-lesion minimum lumen diameter (MLD), % diameter stenosis
(DS), late
loss and angiographic binary restenosis (> 50% DS) at 6 months post procedure.
Data Coordinating Analysis Center
Background summary
This is a single center, prospective, non-randomized study. Approximately 50
patients from one center in Europe will be included in this study. Patients
will be
followed clinically at 30 days, 6 months and 12 months following the index
procedure with the Genous Bio-engineered R stent. In addition, all patients
will be
consented to receive an angiographic follow-up at 6 months post-procedure. All
patients will have blood samples drawn for evaluation of endothelial progenitor
cells (EPC) count at the time of procedure, 30 days and at 6 months
post-procedure.
It is anticipated that the entire duration of this study will be 15 months (3
months to complete enrollment and 12 months follow-up)
All patients will receive a loading dose of atorvastatin (80 mg), aspirin (300
mg) and clopidogrel (300 mg) or ticlopidine (500 mg) if allergic to
clopidogrel. Patient will
be treated with one month of clopidogrel (75mg/day) or ticlopidine 250mg/day and
aspirin (100mg/day) indefinitely. In addition, patients will be treated with
atorvastatin (80mg) for at least 6 months post-procedure. The use of
glycoprotein
IIB/IIIA inhibitors will be at the investigator*s discretion.
Study objective
The primary objective of this study is to determine the feasibility and safety
of the Genous Bio-engineered R stent in the treatment of patients presenting
with acute myocardial infarction with ST segment elevation within 12 hours of
symptoms onset, undergoing an invasive primary angioplasty reperfusion
strategy.
Study design
Single center, prospective, non-randomized study.
Intervention
Blood samples will be taken at the follow up visits, after 30 days, 6 months
and 12 months. A total amount of 50 ml of blood will be taken per visit. A
follow up angiographic will be done 6 months after the procedure.
Study burden and risks
Blood samples will be taken at the follow up visits, after 30 days, 6 months
and 12 months. A total amount of 50 ml of blood will be taken per visit. A
follow up angiographic will be done 6 months after the procedure
5363 NW 35th Avenue
33309 Fort Lauderdale
USA
5363 NW 35th Avenue
33309 Fort Lauderdale
USA
Listed location countries
Age
Inclusion criteria
Patients must meet ALL of the following criteria:
1. Patient >= 18 and <= 80 years of age.
2. ST-segment elevation of >= 1 mm in >= 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >= 1 mm in >= 2 contiguous anterior leads.
3. Treatment of one or two de novo lesions in the same vessel with a total lesion length of <= 30mm. Patients with multi vessel disease not requiring treatment of other lesions within 30 days following treatment of the infarct lesions may be included.
4. Target lesion is located in a native coronary artery.
5. Reference vessel diameter >= 2.5 and <= 3.75 mm by visual estimate.
6. Total lesion length <= 30mm by visual estimate.
7. Acceptable candidate for coronary artery bypass surgery (CABG).
8. The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee.
9. Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent) lasting <= 30 minutes but < 12 hours in duration. If the symptom duration at the time of evaluation is <1 hour, to rule out unstable angina, the symptoms must be unresponsive to nitroglycerin (i.e. ongoing) prior to signing the informed consent. Patients with symptom onset within 12 hours, in whom the symptoms lasted > 1 hour but subsequently resolved, may still be enrolled if the ECG, at the time of the evaluation, shows definitive ongoing ST segment elevation.
Exclusion criteria
1. Woman who are preganant or woman of childbearing potential who do not use adequate contraception.
2. Recipient of heart transplant.
3. Any patient who previously received murine therapeutic antibodies and is know to have exhibited sensitization through the production of Human Anti-mouse Antibodies (HAMA).
4. Patient with life expectancy less than the follow-up period (12 months).
5. Know allergies to aspirin, clopidogrel bisulphate an ticlopidin, heparin or stainless steel.
6. Patients pesenting with cardiogenic shock.
7. Received thrombolytic therapy for the current STEMI.
8. Lesion is not suitable for stenting.
9. Any significant medical condition which in the investigator's opinion may interfere with the patient's optinonal participation in the study.
10. Currently participatinf in an investigational drug or antother device study or subject to inclusion in another investigational srug or other another device study during follow-up.
11. Unprotected left main coronary disease with >50% stenosis.
12. Ostial target lesions.
13. Calcified lesions which cannot be successfully predilated.
14. Targer lesion has excessive tortuosity unsuitable for stent delivery and deplyment.
15. Target lesion involves bifurcation including a side brach >2.5 mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require stenting of diseased side branch).
16. A significant (>50%) stenosis proximal or distal to the target lesion or in another vessel that is not the infarct lesion and requires treatmetn during the acute procedure or within 30 days of enrollment.
17. Documented ejection fraction <25% within 6 weeks of patient enrollmetn on th estudy.
18. pre-treatment with devices other than balloon angioplasty.
19. Prior stent within 10mm target lesion.
20. Patient presenting with possible/probable stent thrombosis.
21 Any patient in whom angiography demonstrates the infarct lesion to be at the site if a previously implanted stent (bare metal or drug-eluting)
22 Patients who underwent coronary stent implamentation within the past 30 days.
Design
Recruitment
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 | NL11812.075.06 |