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

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.

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 <40mm 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 44mm Biomime DES (II generation DES with bioabsorbable polymer, Meril Life Sciences Pvt. Ltd., Gujarat, India). The short stent group (Group B) will be treated by 2 short Biomime 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 (Cardioimaging Centre, Novara, Italy)

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: implantation of a bioabsorbable polymer DES

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • Ospedale Maggiore della Carita
    • Contact: Alessandro Lupi, MD; Phone Number: +3903213733236; Email: lupialessandro1@tin.it
    • Principal Investigator: Alessandro Lupi, MD
    • Sub-Investigator: Andrea Rognoni, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
follow up in-stent late lumen loss	difference between the in-stent coronary lumen measure obtained immediately after coronary percutaneous intervention and the in-stent coronary lumen measure at follow up	6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall mortality	mortality for all causes	1 year
Myocardial infarction	Myocardial infarction (universal definition of myocardial infarction, ACC/AHA/ESC statement) in the territory of the treated coronary artery	1 year
target vessel revascularization	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	1 year
Stent thrombosis	Coronary stent thrombosis according to ARC definition	2 years
MACE (major coronary adverse event)	combined endpoint = presence of overall death or myocardial infarction or target vessel revascularization or stent thrombosis	1 year

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• electronic CRF URL

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: October 27, 2012
• First Submitted That Met QC Criteria: October 27, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary artery disease; drug eluting stent; restenosis; bioabsorbable polymer; late thrombosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 846/CE