Single Long vs Two Short Overlapping Bioabsorbable Polymer DES (ROCCO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Azienda Ospedaliero Universitaria Maggiore della Carita.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT01718106
First received: October 27, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

Multiple overlapping drug-eluting coronary stents (DES) are usually needed to treat long coronary stenoses but this strategy is expensive and the response to overlapping DES has not been extensively studied. The recent availability of bioabsorbable polymer DES could allow treatment of long coronary stenoses without leaving gross burden of non-absorbable polymer in the vessel wall, even in case of overlapping stents.

Thus we planned to evaluate which of the 2 strategies, namely using a single long biabsorbable DES or two shorter biabsorbable DES with minimal overlapping, is better in treating long coronary stenoses.

The study is a spontanous randomized multicenter open-label study. A maximum of 300 patients with stable angina and at leat 1 coronary stenosis >28mm and <35mm of length will be randomized in 1:1 fashion by a Web-based electronic CRF. The long stent group (Group A) will be treated by a single 39mm Infinnium DES (II generation DES with bioabsorbable polymer, Sahjanand tech. Ltd). The short stent group (Group B) will be treated by 2 Infinnium DES positioned with minimal overlapping. The primary end-point of the study will be the 6 moth in-stent late lumen loss. Seconadry end-points will be 1, 6 and 12 month overall mortality, myocardial infarction, target vessel revascularization, stent thrombosis and MACE (combination of the 3 previous clinical end-points). Patients will be evaluated by 6-month control coronary angiography and late lumen loss in the stented vessel will be measured in a quantitative coronary angiography Core Lab (Cardiologic Centre, New Dehli, India)


Condition Intervention
Coronary Artery Disease
Device: implantation of a bioabsorbable polymer DES

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study to Evaluate Segmental Late Loss Comparing Two PCI Strategies Using a Long Stent vs 2 Shorter Stents to Treat Long or Tandem Coronary Stenosis.

Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • follow up in-stent late lumen loss [ Time Frame: 6-month ] [ Designated as safety issue: No ]
    difference between the in-stent coronary lumen measure obtained immediately after coronary percutaneous intervention and the in-stent coronary lumen measure at follow up


Secondary Outcome Measures:
  • overall mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    mortality for all causes

  • Myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Myocardial infarction (universal definition of myocardial infarction, ACC/AHA/ESC statement) in the territory of the treated coronary artery

  • target vessel revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    revascularization of the treated coronary vessel by repeated percutaneous coronary intervention or coronary artery bypass grafting due to restenosis and or symptoms or instrumental signs of myocardial ischemia

  • Stent thrombosis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Coronary stent thrombosis according to ARC definition

  • MACE (major coronary adverse event) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    combined endpoint = presence of overall death or myocardial infarction or target vessel revascularization or stent thrombosis


Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single long bioabsorbable polymer DES
Patients with long coronary stenosis treated by a single long bioabsorbable polymer DES
Device: implantation of a bioabsorbable polymer DES
implantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES
Active Comparator: Two bioabsorbable polymer DES in overlapping
patients with long coronary artery stenosis tretaed by 2 bioabsorbable polymer DES with minimal overlapping
Device: implantation of a bioabsorbable polymer DES
implantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. De novo coronary artery stenosis in a major coronary artery branch (reference diameter 2.5-4.0 mm) with a lenght >28mm and <39mm
  2. Symptoms or instrumental evidence of myocardial ischemia:

    • Chronic stable angina [Canadian Cardiovascular Society Classification]
    • Unstable angina with ECG changes or troponin release (Braunwald Class IB-C, IIB-C, or IIIB-C)
    • Stress ECG or myocardial perfusion imaging or stress echocardiography positive for inducible myocardial ischemia
  3. Written informed consent to the study

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Acute ST elevation myocardial infarction (primary angioplasty)
  3. Cardiogenic shock
  4. Known allergic reactions to aspirin, clopidogrel, prasugrel, heparin, enoxaparin, bivalirudin, steel, chromium, iodiate contrast medium
  5. Platelets <75.000/mm3 or >700.000/mm3 or white blood cells <3.000/mm3.
  6. Partecipation to other studies.
  7. Active or <3 months peptic ulcer or gastrointestinal bleeding
  8. Planned major surgery non delayable .
  9. Comorbidities limiting life expectancy to <1 year.
  10. Unprotected left main disease as target lesion
  11. Chronic total occlusion as target lesion
  12. Bifurcation with side branch > 2.5mm as target lesion
  13. Restenosis as target lesion
  14. saphenous vein graft as target lesion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718106

Contacts
Contact: Alessandro Lupi, MD +3903213733236 lupialessandro1@tin.it

Locations
Italy
Ospedale Maggiore della Carità Not yet recruiting
Novara, Italy, 28100
Contact: Alessandro Lupi, MD    +3903213733236    lupialessandro1@tin.it   
Principal Investigator: Alessandro Lupi, MD         
Sub-Investigator: Andrea Rognoni, MD         
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
Principal Investigator: Alessandro Lupi, MD AOU Maggiore della Carità - Novara
Study Chair: Angelo S Bongo, MD AOU Maggiore della Carità - Novara
  More Information

Additional Information:
No publications provided

Responsible Party: Lupi Alessandro, Dr Alessandro Lupi, Cardiologia Ospedaliera, AOU Maggiore della Carità, Novara., Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01718106     History of Changes
Other Study ID Numbers: 846/CE
Study First Received: October 27, 2012
Last Updated: October 27, 2012
Health Authority: Italy: Ministero della Salute

Keywords provided by Azienda Ospedaliero Universitaria Maggiore della Carita:
coronary artery disease
drug eluting stent
bioabsorbable polymer
percutaneous coronary intervention
restenosis
late thrombosis

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

ClinicalTrials.gov processed this record on October 19, 2014