Single Long vs Two Short Overlapping Bioabsorbable Polymer DES

NCT ID: NCT01718106

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-03-31

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)

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single long bioabsorbable polymer DES

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

Group Type: ACTIVE_COMPARATOR

implantation of a bioabsorbable polymer DES

Intervention Type: DEVICE

implantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES

Two bioabsorbable polymer DES in overlapping

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

Group Type: ACTIVE_COMPARATOR

implantation of a bioabsorbable polymer DES

Intervention Type: DEVICE

implantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES

Interventions

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role: lead

Responsible Party

Lupi Alessandro

Dr Alessandro Lupi, Cardiologia Ospedaliera, AOU Maggiore della Carità, Novara.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Lupi, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Maggiore della Carità - Novara

Angelo S Bongo, MD

Role: STUDY_CHAIR

AOU Maggiore della Carità - Novara

Locations

Ospedale Maggiore della Carità

Novara, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessandro Lupi, MD

Role: CONTACT

lupialessandro1@tin.it

+3903213733236

Facility Contacts

Alessandro Lupi, MD

Role: primary

lupialessandro1@tin.it

+3903213733236

Other Identifiers

846/CE

Identifier Type: -

Identifier Source: org_study_id