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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Percutaneous transluminal Coronary Angioplasty
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Late stent malapposition, stent thrombosis, IVUS, non-polimeric stent

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital de la Santa Creu y Sant PauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Polimeric-PES

Non-Polimeric PES

Arm Description

Arm receiving polimeric stent (Taxus)

Arm receiving non-polimeric PES (axxion)

Outcomes

Primary Outcome Measures

Intra coronary ultrasound analysis to verify stent malapposition at follow-up

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.

Full Information

First Posted
December 28, 2010
Last Updated
June 16, 2011
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT01375855
Brief Title
Late Incomplete Stent Apposition Evaluation II: Comparison Between Polimer-based and No-polimer Stent System. IVUS Based Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Late stent malapposition, stent thrombosis, IVUS, non-polimeric stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polimeric-PES
Arm Type
Active Comparator
Arm Description
Arm receiving polimeric stent (Taxus)
Arm Title
Non-Polimeric PES
Arm Type
Active Comparator
Arm Description
Arm receiving non-polimeric PES (axxion)
Intervention Type
Procedure
Intervention Name(s)
Percutaneous transluminal Coronary Angioplasty
Intervention Description
Coronary artery stent implantation
Primary Outcome Measure Information:
Title
Intra coronary ultrasound analysis to verify stent malapposition at follow-up
Time Frame
9 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manel Sabate, MD, PhD
Phone
0034935565851
Email
msabatet@santpau.es
First Name & Middle Initial & Last Name or Official Title & Degree
Clarissa Cola, MD
Phone
0034935565851
Email
clarissacola@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manel Sabate, MD, PhD
Organizational Affiliation
Hospital de la Santa Creu Y Sant Pau, Unidad de Hemodinamica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu y Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manel sabate, MD, PhD
Phone
0034935565851
Email
msabatet@santpau.es
First Name & Middle Initial & Last Name & Degree
Clarissa Cola, MD
Phone
0034935565851
Email
clarissacola@gmail.com
First Name & Middle Initial & Last Name & Degree
Manel Sabate, MD, PhD
First Name & Middle Initial & Last Name & Degree
Victoria Martin Yuste, MD
First Name & Middle Initial & Last Name & Degree
Clarissa Cola, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17919574
Citation
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. doi: 10.1016/j.jacc.2007.07.038. Epub 2007 Aug 27. No abstract available.
Results Reference
background
PubMed Identifier
24803435
Citation
Shiratori Y, Cola C, Brugaletta S, Alvarez-Contreras L, Martin-Yuste V, del Blanco BG, Ruiz-Salmeron R, Diaz J, Pinar E, Marti V, Garcia-Picart J, Sabate M. Randomized comparison between polymer-free versus polymer-based paclitaxel-eluting stent: two-year final clinical results. Circ Cardiovasc Interv. 2014 Jun;7(3):312-21. doi: 10.1161/CIRCINTERVENTIONS.113.000800. Epub 2014 May 6.
Results Reference
derived

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

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