Single Long vs Two Short Overlapping Bioabsorbable Polymer DES

NCT01718106 | Unknown DMC

• 1 other identifier: 846/CE
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

coronary artery disease; drug eluting stent; bioabsorbable polymer; percutaneous coronary intervention; restenosis; late thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• overall mortality

  1 year

• Myocardial infarction

  1 year

• target vessel revascularization

  1 year

• Stent thrombosis

  2 years

• MACE (major coronary adverse event)

  1 year

Study Arms (2)

Single long bioabsorbable polymer DES

ACTIVE COMPARATOR

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

Device: implantation of a bioabsorbable polymer DES

Two bioabsorbable polymer DES in overlapping

ACTIVE COMPARATOR

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

Device: implantation of a bioabsorbable polymer DES

Interventions

implantation of a bioabsorbable polymer DES DEVICE

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

Single long bioabsorbable polymer DES; Two bioabsorbable polymer DES in overlapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• De novo coronary artery stenosis in a major coronary artery branch (reference diameter 2.5-4.0 mm) with a lenght \>28mm and \<39mm
• 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
• Written informed consent to the study

You may not qualify if:

• Pregnancy or lactation
• Acute ST elevation myocardial infarction (primary angioplasty)
• Cardiogenic shock
• Known allergic reactions to aspirin, clopidogrel, prasugrel, heparin, enoxaparin, bivalirudin, steel, chromium, iodiate contrast medium
• Platelets \<75.000/mm3 or \>700.000/mm3 or white blood cells \<3.000/mm3.
• Partecipation to other studies.
• Active or \<3 months peptic ulcer or gastrointestinal bleeding
• Planned major surgery non delayable .
• Comorbidities limiting life expectancy to \<1 year.
• Unprotected left main disease as target lesion
• Chronic total occlusion as target lesion
• Bifurcation with side branch \> 2.5mm as target lesion
• Restenosis as target lesion
• saphenous vein graft as target lesion.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

Ospedale Maggiore della Carità

Novara, 28100, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Alessandro Lupi, MD

  AOU Maggiore della Carità - Novara

  PRINCIPAL INVESTIGATOR

• Angelo S Bongo, MD

  AOU Maggiore della Carità - Novara

  STUDY CHAIR

Central Study Contacts

Alessandro Lupi, MD

CONTACT

+3903213733236; lupialessandro1@tin.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Alessandro Lupi, Cardiologia Ospedaliera, AOU Maggiore della Carità, Novara.

Study Record Dates

• First Submitted: October 27, 2012
• First Posted: October 31, 2012
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

IT (1)