Italian Diffuse/Multivessel Disease ABSORB Prospective Registry: IT-Disappears
1 other identifier
interventional
1,000
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Dec 2013
Shorter than P25 for phase_4 coronary-artery-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 19, 2014
November 1, 2014
1 year
November 27, 2013
November 18, 2014
Conditions
Outcome Measures
Primary Outcomes (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).
30 days, 6 months, 1 year, and then yearly up to 5 years after the index procedure.
Secondary Outcomes (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.
30 days, 6 months, 1 year, and then yearly up to 5 years after the index procedure.
Other Outcomes (1)
Any type of angina post procedure measured by means of the Cardio Test, proposed by the ANMCO (Associazione Nazionale Medici Cardiologic Ospedalieri)
30 days, 6 months, 1 year, and then yearly up to 5 years after the index procedure.
Study Arms (3)
long single vessel disease
EXPERIMENTALABSORB implantation for long single vessel disease
multivessel disease ABSORB only
EXPERIMENTALmultivessel disease treated with ABSORB implantation only
multivessel disease "hybrid"
EXPERIMENTALmultivessel disease treated with ABSORB implantation and other devices such as drug eluting stents
Interventions
ABSORB implantation for long (\> 24mm) single vessel disease
Eligibility Criteria
You may qualify if:
- Patient must be at least 18 years of age at the time of signing the Informed Consent Form
- Patient is to be treated for de novo lesions located in previously untreated vessels.
- Patient must agree to undergo all required follow-up visits and data collection.
- 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:
- Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or
- Unstable angina / non ST-elevation myocardial infarction
- ST-elevation myocardial infarction with de novo culprit lesion.
You may not qualify if:
- Known intolerance to any of the device components
- Contraindication to dual antiplatelet therapy (DAPT)
- Lesion in a saphenous vein graft
- Lesion to left internal mammary artery
- Unprotected left main stenosis
- Woman with childbearing potential
- Age \< 18y/o
- Concomitant indication to open heart surgery
- Inability to provide written informed consent
- Enrolment in another study within 1 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogiolead
- Abbott Medical Devicescollaborator
Study Sites (2)
Istituto Clinico S. Ambrogio
Milan, 20149, Italy
Ospedale Cisanello
Pisa, 56124, Italy
Related Publications (2)
De Carlo M, Testa L, Leoncini M, Nicolini E, Varbella F, Cortese B, Ribichini F, Bartorelli AL, Calabria P, Indolfi C, Tomai F, Loi B, Fischietti D, Tarantini G, Bedogni F, Petronio AS. Two-year clinical outcomes of the "Italian diffuse/multivessel disease absorb prospective registry" (IT-DISAPPEARS). Int J Cardiol. 2019 Sep 1;290:21-26. doi: 10.1016/j.ijcard.2019.04.095. Epub 2019 May 3.
PMID: 31104821DERIVEDTesta L, Biondi Zoccai G, Tomai F, Ribichini F, Indolfi C, Tamburino C, Bartorelli A, Petronio AS, Bedogni F, De Carlo M. Italian Diffuse/Multivessel Disease ABSORB Prospective Registry (IT-DISAPPEARS). Study design and rationale. J Cardiovasc Med (Hagerstown). 2015 Mar;16(3):253-8. doi: 10.2459/JCM.0000000000000219.
PMID: 25469734DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Bedogni, MD
Istituto Clinico S. Ambrogio
- PRINCIPAL INVESTIGATOR
Anna Sonia Petronio, Prof
Univ. of Pisa, Ospedale Cisanello
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
November 27, 2013
First Posted
December 9, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2014
Study Completion
June 1, 2015
Last Updated
November 19, 2014
Record last verified: 2014-11