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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01375855
First received: December 28, 2010
Last updated: June 16, 2011
Last verified: February 2007
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: Percutaneous transluminal Coronary Angioplasty
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Intra coronary ultrasound analysis to verify stent malapposition at follow-up [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 9 months and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: October 2007
Arms Assigned Interventions
Active Comparator: Polimeric-PES
Arm receiving polimeric stent (Taxus)
Procedure: Percutaneous transluminal Coronary Angioplasty
Coronary artery stent implantation
Active Comparator: Non-Polimeric PES
Arm receiving non-polimeric PES (axxion)
Procedure: Percutaneous transluminal Coronary Angioplasty
Coronary artery stent implantation

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375855

Contacts
Contact: Manel Sabate, MD, PhD 0034935565851 msabatet@santpau.es
Contact: Clarissa Cola, MD 0034935565851 clarissacola@gmail.com

Locations
Spain
Hospital de la Santa Creu y Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Manel sabate, MD, PhD    0034935565851    msabatet@santpau.es   
Contact: Clarissa Cola, MD    0034935565851    clarissacola@gmail.com   
Principal Investigator: Manel Sabate, MD, PhD         
Sub-Investigator: Victoria Martin Yuste, MD         
Sub-Investigator: Clarissa Cola, MD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Manel Sabate, MD, PhD Hospital de la Santa Creu Y Sant Pau, Unidad de Hemodinamica
  More Information

Publications:
Responsible Party: Unitat de Hemodinàmic. Servei Cardiologia
ClinicalTrials.gov Identifier: NCT01375855     History of Changes
Other Study ID Numbers: 2007-000142-12
Study First Received: December 28, 2010
Last Updated: June 16, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Late stent malapposition
stent thrombosis
IVUS
non-polimeric stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 08, 2014