Single Long vs Two Short Overlapping Bioabsorbable Polymer DES

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: implantation of a bioabsorbable polymer DES

• Registration Number: NCT01718106
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-27
• Study First Submitted QC: 2012-10-27
• Study First Posted: 2012-10-31
• Study Start: 2014-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26
• Primary Completion: 2015-12
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single long bioabsorbable polymer DES	implantation of a bioabsorbable polymer DES	Patients with long coronary stenosis treated by a single long bioabsorbable polymer DES
Two bioabsorbable polymer DES in overlapping	implantation of a bioabsorbable polymer DES	patients with long coronary artery stenosis tretaed by 2 bioabsorbable polymer DES with minimal overlapping

Primary Outcome Measures

Name	Time	Method
follow up in-stent late lumen loss	6-month	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

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

Trial Locations

Locations (1)

Ospedale Maggiore della Carità; 🇮🇹 Novara, Italy