Single Long vs Two Short Overlapping Bioabsorbable Polymer DES

Coronary Artery Disease Clinical Trial

— ROCCO  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01718106
• Other study ID #: 846/CE
• Status: Recruiting
• Phase: N/A
• First received: October 27, 2012
• Last updated: March 25, 2015
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: Alessandro Lupi, MD
• Phone: +3903213733236
• Email: lupialessandro1[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: Ministero della Salute
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 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

Locations

Country	Name	City	State
Italy	Ospedale Maggiore della Carità	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	overall mortality	mortality for all causes	1 year	Yes
Secondary	Myocardial infarction	Myocardial infarction (universal definition of myocardial infarction, ACC/AHA/ESC statement) in the territory of the treated coronary artery	1 year	Yes
Secondary	target vessel revascularization	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	1 year	No
Secondary	Stent thrombosis	Coronary stent thrombosis according to ARC definition	2 years	Yes
Secondary	MACE (major coronary adverse event)	combined endpoint = presence of overall death or myocardial infarction or target vessel revascularization or stent thrombosis	1 year	No

External Links

•   electronic CRF URL