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

University Hospital Maggiore della Carità of Novara

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: implantation of a bioabsorbable polymer DES

Study type: Interventional

Funder types: Other

Identifiers

NCT01718106

846/CE

Details and patient eligibility

About

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)

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Single long bioabsorbable polymer DES

Active Comparator group

Description:

Patients with long coronary stenosis treated by a single long bioabsorbable polymer DES

Treatment:

Device: implantation of a bioabsorbable polymer DES

Two bioabsorbable polymer DES in overlapping

Active Comparator group

Description:

patients with long coronary artery stenosis tretaed by 2 bioabsorbable polymer DES with minimal overlapping

Treatment:

Device: implantation of a bioabsorbable polymer DES