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

Coronary Artery Disease Clinical Trial

— LISAII  

Official title:

Late Incomplete Stent Apposition Evaluation II: Vascular Effects Evaluation After Polimer and No-polimer Based Coronary Artery Drug Eluting Stent Ilmplantation. An IVUS Based Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01375855
• Other study ID #: 2007-000142-12
• Status: Recruiting
• Phase: Phase 4
• First received: December 28, 2010
• Last updated: June 16, 2011
• Start date: October 2007

Study information

• Verified date: February 2007
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Manel Sabate, MD, PhD
• Phone: 0034935565851
• Email: msabatet[@]santpau.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous transluminal Coronary Angioplasty
Coronary artery stent implantation

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu y Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Hong MK, Mintz GS, Lee CW, Park DW, Lee SW, Kim YH, Kang DH, Cheong SS, Song JK, Kim JJ, Park SW, Park SJ. Impact of late drug-eluting stent malapposition on 3-year clinical events. J Am Coll Cardiol. 2007 Oct 9;50(15):1515-6. Epub 2007 Aug 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra coronary ultrasound analysis to verify stent malapposition at follow-up		9 months	No
Secondary	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	No