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Assessment of Surface Coverage of Two Types of DES in Diabetes Mellitus and Non- Diabetes Mellitus

29. marts 2010 opdateret af: Harbin Medical University

Assessment of Surface Coverage of Polymer-based Sirolimus-eluting Stent( Cypher ) or Polymer-free Paclitaxel-eluting Stent (YinYi )in Diabetes Mellitus and Non- Diabetes Mellitus Patients by Optical Coherence Tomography

Diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis. Both clinical and angiographic outcomes following percutaneous coronary intervention (PCI) are poor in patients with DM compared with those without DM. Autopsy study has shown delayed neointimal healing with inadequate endothelialization and persistent stent surface fibrin deposition after DES implantation in DM patients. This might partially contribute to the high risk of late stent thrombosis.

YINYI Polymer-Free paclitaxel stent is a domestic new type stent with bare metal base with micro porous surface. However, limited data is available in vivo about the surface coverage after stent implantation in DM patients because of lack of sensitive imaging modalities. Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound(IVUS)that allows high-resolution tomographic intravascular imaging. Furthermore, several studies have demonstrated the feasibility of OCT to quantitatively evaluate the surface coverage and stent conditions in the follow up after PCI .

Therefore, the aim of this study was to analyze the surface coverage and late malapposition after two types of DES implantation in DM patients compared with non-DM patients by using OCT and IVUS

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Bo Yu, MD, PhD
  • Telefonnummer: 86-0451-86605180
  • E-mail: yubodr@163.com

Studiesteder

    • Heilong jiang
      • Harbin, Heilong jiang, Kina, 150081
        • Rekruttering
        • The second Affiliated Hospital of Harbin Medical University
        • Kontakt:
          • Bo Yu, MD,PhD
          • Telefonnummer: 86-0451-86605180
          • E-mail: yubodr@163.com
        • Ledende efterforsker:
          • Bo Yu, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

General Inclusion Criteria:

  1. Age : 18-75Y
  2. Patients diagnosed as type 2 DM or non-DM.

Angiographic Inclusion Criteria:

  1. Patients were considered eligible if they have one significant (>70%) angiographic stenosis lesions in native coronary vessel by CAG.
  2. Each target is de novo lesion that can be treated with 1-2 stents.
  3. Reference vessel diameter of 2.5 to 4.0 mm.

Exclusion Criteria

General Exclusion Criteria:

  1. ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
  2. Life expectancy <12 months due to another medical condition.
  3. Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus and paclitaxel or structurally related compounds.
  4. Creatinine level more than 2.0mg/dL or ESRD.
  5. Severe hepatic dysfunction (more than 3 times normal reference values).
  6. Planned surgery procedure≤12 months post-index procedure.
  7. Known allergy to stainless steel.
  8. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
  9. Patient is not clinically appropriate for OCT evaluation in the opinion of investigator.

Angiographic Exclusion Criteria:

  1. Study lesion is ostial in location (within 3.0 mm of vessel origin).
  2. Study lesion involving arterial segments with highly tortuous anatomy.
  3. Complex lesion morphologies (bifurcation needs two stents technique, left main lesion, chronic obstructive occlusion, severe thrombus, heavy calcification).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Gruppe A: DM
Koronararteriesygdom med diabetes mellitus
Cypher stent or YinYi stent randomly implanted in coronary artery disease
Aktiv komparator: Group B: Non-DM
Coronary artery disease with diabetes mellitus
Cypher stent or YinYi stent randomly implanted in coronary artery disease

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent)implantation
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
Tidsramme: 12 months
12 months
To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
Tidsramme: 6 months
6 months
To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
Tidsramme: 12 months
12 months
To investigate the differences of surface coverage pattern,the incidence of malapposition and in-stent thrombosis between Cypher stent and YINYI in diabetic patients
Tidsramme: 6 and 12 months.
6 and 12 months.
To investigate the differences of surface coverage pattern,malapposition and the incidence of thrombosis between Cypher stent and YINYI in non-diabetic patients
Tidsramme: 6 and 12 months.
6 and 12 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2009

Primær færdiggørelse (Forventet)

1. december 2010

Studieafslutning (Forventet)

1. juni 2011

Datoer for studieregistrering

Først indsendt

1. december 2009

Først indsendt, der opfyldte QC-kriterier

1. december 2009

Først opslået (Skøn)

2. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. marts 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. marts 2010

Sidst verificeret

1. december 2009

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Koronararteriesygdom

3
Abonner