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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Percutaneous transluminal Coronary Angioplasty

• Registration Number: NCT01375855
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-02
• Study Start: 2007-10
• Study First Submitted: 2010-12-28
• Study First Submitted QC: 2011-06-16
• Last Update Submitted: 2011-06-16
• Study First Posted: 2011-06-17
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polimeric-PES	Percutaneous transluminal Coronary Angioplasty	Arm receiving polimeric stent (Taxus)
Non-Polimeric PES	Percutaneous transluminal Coronary Angioplasty	Arm receiving non-polimeric PES (axxion)

Primary Outcome Measures

Name	Time	Method
Intra coronary ultrasound analysis to verify stent malapposition at follow-up	9 months

Secondary Outcome Measures

Name	Time	Method
Clinical events (myocardial infarction, TLR,at 1, 9, 12, 24 months follow-up:; Incidence of restenosis with QCA at 9 months follow-up Intimal hiperplasia measured by IVUS at 9 months follow-up; Stent Thrombosis.	9 months and 2 years

Trial Locations

Locations (1)

Hospital de la Santa Creu y Sant Pau; 🇪🇸 Barcelona, Spain