Late Incomplete Stent Apposition Evaluation II: Comparison Between Polimer-based and No-polimer Stent System. IVUS Based Study (LISAII)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Procedure: Percutaneous transluminal Coronary Angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01375855

2007-000142-12

Details and patient eligibility

About

Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months follow-up. The investigators sought to compare the two stent types with the same drug to verify the polimer role. The polimer itself seems to provoke inflammation and hypersensibility if the arterial wall and it seems to be the base of a process of positive remodeling found at drug eluting stent implantation site.

This positive remodeling is the mechanism producing late stent malapposition which on its turn can determine stent thrombosis, as demonstrated by pathological studies. At the same time the investigators will study the incidence of clinical events like myocardial infarction, stent thrombosis, TLR and death along with the incidence of angiographic restenosis at 2 years follow up.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with coronary artery stenosis in one, two or three vessels, and with objective evidence of isquemia.
• The stenosis must allow IVUS analisis, must be treatable with angioplasty with stent
• Target Vessel diameter must be between 2.25- 4 mm with QCA.
• Patients must sign informed consent
• Patients and their physician must accept the angiographic follow-up

Exclusion criteria

• 18 years old patients
• SCA within the last 72 hours, or patients with CK twice over the upper normal limit
• Pregnancy
• Target vessel diameter < 2.25 or > 4 mm by QCA
• Previous brakitherapy or DES in the target lesion
• Restenotic lesion
• -Allergy to aspirin, clopidogrel or ticlopidin
• Patients enrolled in other studies or trials
• By-pass graft lesions
• Real bifurcationa lesions
• Severe Renal insufficiency (creatinin clearance < 30 ml/min).
• Severe Liver failure(GOT y GPT > 3 times the upper normal limit)
• Life expectancy < 1 year because of other pathologies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Polimeric-PES

Active Comparator group

Description:

Arm receiving polimeric stent (Taxus)

Treatment:

Procedure: Percutaneous transluminal Coronary Angioplasty

Non-Polimeric PES

Active Comparator group

Description:

Arm receiving non-polimeric PES (axxion)

Treatment:

Procedure: Percutaneous transluminal Coronary Angioplasty