Single Long vs Two Short Overlapping Bioabsorbable Polymer DES (ROCCO)
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Purpose
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 <35mm 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 39mm Infinnium DES (II generation DES with bioabsorbable polymer, Sahjanand tech. Ltd). The short stent group (Group B) will be treated by 2 Infinnium 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 (Cardiologic Centre, New Dehli, India)
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Device: implantation of a bioabsorbable polymer DES |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
- follow up in-stent late lumen loss [ Time Frame: 6-month ] [ Designated as safety issue: No ]difference between the in-stent coronary lumen measure obtained immediately after coronary percutaneous intervention and the in-stent coronary lumen measure at follow up
- overall mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]mortality for all causes
- Myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Myocardial infarction (universal definition of myocardial infarction, ACC/AHA/ESC statement) in the territory of the treated coronary artery
- target vessel revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]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
- Stent thrombosis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Coronary stent thrombosis according to ARC definition
- MACE (major coronary adverse event) [ Time Frame: 1 year ] [ Designated as safety issue: No ]combined endpoint = presence of overall death or myocardial infarction or target vessel revascularization or stent thrombosis
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Single long bioabsorbable polymer DES
Patients with long coronary stenosis treated by a single long bioabsorbable polymer DES
|
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
|
|
Active Comparator: Two bioabsorbable polymer DES in overlapping
patients with long coronary artery stenosis tretaed by 2 bioabsorbable polymer DES with minimal overlapping
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Alessandro Lupi, MD | +3903213733236 | lupialessandro1@tin.it |
| Italy | |
| Ospedale Maggiore della Carità | Not yet recruiting |
| Novara, Italy, 28100 | |
| Contact: Alessandro Lupi, MD +3903213733236 lupialessandro1@tin.it | |
| Principal Investigator: Alessandro Lupi, MD | |
| Sub-Investigator: Andrea Rognoni, MD | |
| Principal Investigator: | Alessandro Lupi, MD | AOU Maggiore della Carità - Novara |
| Study Chair: | Angelo S Bongo, MD | AOU Maggiore della Carità - Novara |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lupi Alessandro, Dr Alessandro Lupi, Cardiologia Ospedaliera, AOU Maggiore della Carità, Novara., Azienda Ospedaliero Universitaria Maggiore della Carita |
| ClinicalTrials.gov Identifier: | NCT01718106 History of Changes |
| Other Study ID Numbers: | 846/CE |
| Study First Received: | October 27, 2012 |
| Last Updated: | October 27, 2012 |
| Health Authority: | Italy: Ministero della Salute |
Keywords provided by Azienda Ospedaliero Universitaria Maggiore della Carita:
|
coronary artery disease drug eluting stent bioabsorbable polymer |
percutaneous coronary intervention restenosis late thrombosis |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Diethylstilbestrol Estrogens, Non-Steroidal Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013