Patients with diffuse CAD undergoing percutaneous treatment on a native coronary vessel with planned implantation of two DES in overlapping with a total stent length 33 mm for diffuse coronary disease in vessels with a reference vessel diameter 2.25-4.0 mm. MedDRA version: 9.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Trade Name: INTEGRILIN
Product Name: INTEGRILIN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Eptifibatide
Concentration unit: µg microgram(s)
Concentration type: equal
Concentratio
Sponsors
Fondazione Mediolanum Onlus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female able to understand and sign a witnessed informed consent Age 8805; 18 yo Patients with stable CCS 1-4 or unstable angina pectoris but with the most recent anginal episode occurring 48 hours before the procedure or documented silent ischemia Stable Hemodynamic conditions systolic BP 100 HR 40 100 . No clinical and ECG changes suggestive of ongoing acute or recent 48 hours myocardial infarction. Angiographic evidence of a de novo lesion 50 requiring implantation of two DES in overlapping with a total stent length 33 mm and reference vessel diameter between 2.5 and 4.0 mm by visual estimation in one coronary vessel. Multiple lesions in the same vessels can be included but at least one lesion should require implantation of two DES in overlapping with a total stent length 33 mm . The definition of multivessel disease requires an intention to treat at least two lesions with a least one with the characteristics reported above in two different major epicardial segments. For example, the presence of a lesion in the left anterior descending artery and in the obtuse marginal or the presence of a lesions in the right postero-lateral branch and in a diagonal branch will qualify as multivessel. The presence of lesions in the left anterior descending artery and in the diagonal branch will not qualify as multivessel. Bifurcation lesions and ostial lesions can be included, but only if at least two DES in overlapping with a total stent length 33 mm are implanted in the same branch. When treating diffuse lesion in the same vessel, overlapping stenting is recommended with high pressure 14 atm post-dilation of the overlap zone. There is no maximum stent length to treat one coronary vessel. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Female sex with childbearing potential Age 18 years Ongoing or recent episode 48 hours of unstable coronary artery disease including both ST-elevation and non-ST-elevation acute coronary syndromes Administration of any GP IIb/IIIa inhibitors during the previous 2 weeks Serum creatinine 2.5 mg/dl or with a creatinine clearance 40mL/min Ongoing serious bleeding or bleeding diathesis Previous stroke in the last 6 months Major surgery within the previous 6 weeks Platelet count 100,000 per mm3 Ejection Fraction below 30 The patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or sensitivity to contrast which cannot be adequately pre-medicated. Hemodynamic instability systolic blood pressure 100 mm Hg; heart rate 40 bpm or 100 bpm; complex ventricular arrhythmias; AV block requiring balloon counterpulsation or inotropic support. The patient is simultaneously participating in another device or drug study. Patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this study. Positive clinical history for intracranial neoplasia, AV malformation, aneurysm. INR 8805; 2.0 or prothrombin time 1.2 times upper limit of normality Clinically manifested reduced liver function Programmed surgery within six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: compare the efficacy and, secondarily, the safety and effectiveness of pre-procedural use of the Gp IIb/IIIa inhibitor eptifibatide in comparison to placebo in patients with diffuse CAD undergoing multiple DES implantation.;Secondary Objective: The primary end point will be the rate of post-procedural peak CK-MB ratio values above the upper limit of normal. Secondary end-points will include the composite of death, non-fatal myocardial infarction MI , urgent target vessel revascularization TVR , and thrombotic bailout GP IIb/IIIa inhibitor therapy within 180 days, and in-hospital, 1-month, 6-months major adverse cardiovascular events MACE , defined as the composite of cardiovascular death, non-fatal MI, or urgent TVR. As additional safety and efficacy tertiary end-points we will assess the rate of major and minor bleedings defined according to the Thrombolysis In Myocardial Infarction criteria . Angiographic end-points will include the procedural changes in Thrombolysis In Myocardial Infarction TIMI flow, corrected TIMI frame count, and myocardial blush grade.;Primary end point(s): -The primary end point will be the rate of post-procedural peak CK-MB ratio values above the upper limit of normal. | — |
Countries
Italy
Outcome results
None listed