Clinical trial NCT01718106: Single Long vs Two Short Overlapping Bioabsorbable Polymer DES
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
drug eluting stent
bioabsorbable polymer
percutaneous coronary intervention
restenosis
late thrombosis
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: follow up in-stent late lumen loss
timeFrame: 6-month
Secondary outcomes:
measure: overall mortality
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: target vessel revascularization
timeFrame: 1 year
measure: Stent thrombosis
timeFrame: 2 years
measure: MACE (major coronary adverse event)
timeFrame: 1 year
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità
Study officials:
affiliation: AOU Maggiore della Carità - Novara
name: Alessandro Lupi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOU Maggiore della Carità - Novara
name: Angelo S Bongo, MD
role: STUDY_CHAIR
References: