INtegrilin plus STenting to Avoid Myocardial Necrosis Trial - INSTANT

• Conditions: 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: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome

• Registration Number: EUCTR2007-002617-39-IT
• Lead Sponsor: Fondazione Mediolanum Onlus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified