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

NCT01375855 | Unknown Phase 4 DMC

• 1 other identifier: 2007-000142-12
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Late stent malapposition; stent thrombosis; IVUS; non-polimeric stent

Outcome Measures

Primary Outcomes (1)

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

  9 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Polimeric-PES

ACTIVE COMPARATOR

Arm receiving polimeric stent (Taxus)

Procedure: Percutaneous transluminal Coronary Angioplasty

Non-Polimeric PES

ACTIVE COMPARATOR

Arm receiving non-polimeric PES (axxion)

Procedure: Percutaneous transluminal Coronary Angioplasty

Interventions

Percutaneous transluminal Coronary Angioplasty PROCEDURE

Coronary artery stent implantation

Non-Polimeric PES; Polimeric-PES

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu y Sant Pau

Barcelona, Spain, 08025, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 17919574 BACKGROUND

• 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.

  PMID: 24803435 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, Balloon, Coronary

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty, Balloon; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Manel Sabate, MD, PhD

  Hospital de la Santa Creu Y Sant Pau, Unidad de Hemodinamica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manel Sabate, MD, PhD

CONTACT

0034935565851; msabatet@santpau.es

Clarissa Cola, MD

CONTACT

0034935565851; clarissacola@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: June 17, 2011
• Study Start: October 1, 2007
• Last Updated: June 17, 2011

Record last verified: 2007-02

Locations

ES (1)