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Italian Diffuse/Multivessel Disease ABSORB Prospective Registry: IT-Disappears

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ClinicalTrials.gov Identifier: NCT02004730
Recruitment Status : Unknown
Verified November 2014 by Luca Testa, Istituto Clinico Sant'Ambrogio.
Recruitment status was:  Recruiting
First Posted : December 9, 2013
Last Update Posted : November 19, 2014
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Luca Testa, Istituto Clinico Sant'Ambrogio

Brief Summary:
The purpose of this study is to determine whether patients with diffuse or multivessel coronary artery disease may benefit from the percutaneous implantation of the device ABSORB in larger extent with respect to the general population of patients undergoing percutaneous treatment of coronary artery disease.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: ABSORB implantation Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Italian Diffuse/Multivessel Disease ABSORB Prospective Registry Under the Auspices of Società Italiana di Cardiologia Invasive-GISE (IT-DISAPPEARS)
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: long single vessel disease
ABSORB implantation for long single vessel disease
Device: ABSORB implantation
ABSORB implantation for long (> 24mm) single vessel disease

Experimental: multivessel disease ABSORB only
multivessel disease treated with ABSORB implantation only
Device: ABSORB implantation
ABSORB implantation for long (> 24mm) single vessel disease

Experimental: multivessel disease "hybrid"
multivessel disease treated with ABSORB implantation and other devices such as drug eluting stents
Device: ABSORB implantation
ABSORB implantation for long (> 24mm) single vessel disease




Primary Outcome Measures :
  1. the cumulative hierarchical incidence of major adverse cardiac events (MACE) defined as: cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). [ Time Frame: 30 days, 6 months, 1 year, and then yearly up to 5 years after the index procedure. ]

Secondary Outcome Measures :
  1. All causes mortality, clinically driven TLR, clinically driven target vessel revascularization (TVR), any revascularisation (non TLR, non TVR) and ARC-defined stent thrombosis, at any time point, any type of angina. [ Time Frame: 30 days, 6 months, 1 year, and then yearly up to 5 years after the index procedure. ]

Other Outcome Measures:
  1. Any type of angina post procedure measured by means of the Cardio Test, proposed by the ANMCO (Associazione Nazionale Medici Cardiologic Ospedalieri) [ Time Frame: 30 days, 6 months, 1 year, and then yearly up to 5 years after the index procedure. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must be at least 18 years of age at the time of signing the Informed Consent Form
  2. Patient is to be treated for de novo lesions located in previously untreated vessels.
  3. Patient must agree to undergo all required follow-up visits and data collection.
  4. Patient must have indication to percutaneous coronary intervention for:

    • multivessel disease (at least two significant stenoses in two different segments NOT as a bifurcation lesion; for patients with two vessel disease at least 1 lesion must be >24 mm and must be treated with the BVS; for patients with 3 vessel disease a hybrid approach is acceptable provided that 2 vessels are treated with BVS),

      • long (>24 mm) single vessel disease following:

        1. Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or
        2. Unstable angina / non ST-elevation myocardial infarction
        3. ST-elevation myocardial infarction with de novo culprit lesion.

Exclusion Criteria:

  1. Known intolerance to any of the device components
  2. Contraindication to dual antiplatelet therapy (DAPT)
  3. Lesion in a saphenous vein graft
  4. Lesion to left internal mammary artery
  5. Unprotected left main stenosis
  6. Woman with childbearing potential
  7. Age < 18y/o
  8. Concomitant indication to open heart surgery
  9. Inability to provide written informed consent
  10. Enrolment in another study within 1 month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004730


Contacts
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Contact: Luca Testa, MD, PhD +39-3490808660 luctes@gmail.com

Locations
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Italy
Istituto Clinico S. Ambrogio Recruiting
Milan, Italy, 20149
Contact: Luca Testa, Md, PhD    +39-3490808660    luctes@gmail.com   
Principal Investigator: Francesco Bedogni, MD         
Ospedale Cisanello Recruiting
Pisa, Italy, 56124
Contact: Marco De Carlo, MD         
Principal Investigator: Anna Sonia Petronio, Prof         
Sponsors and Collaborators
Istituto Clinico Sant'Ambrogio
Abbott Medical Devices
Investigators
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Principal Investigator: Francesco Bedogni, MD Istituto Clinico S. Ambrogio
Principal Investigator: Anna Sonia Petronio, Prof Univ. of Pisa, Ospedale Cisanello

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Luca Testa, MD, PhD, Istituto Clinico Sant'Ambrogio
ClinicalTrials.gov Identifier: NCT02004730     History of Changes
Other Study ID Numbers: IT-Disappears
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

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