To compare the BIOTRONIK Orsiro Limus Eluting Stent System (LESS) with the Abbott Xience Prime* Llimus Eluting Stent System (LESS) with respect to in-stent Late Lumen Loss (LLL) in a non-inferiority study in de novo coronary lesions at 9 months.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In-stent LLL at 9 months post procedure by core laboratory QCA analysis
Secondary outcome
1. Clinically driven Target Lesion Revascularization (TLR) at 1, 6 and 12
months post-procedure
2. Clinically driven Target Vessel Revascularization (TVR) at 1, 6 and 12
months post-procedure
3. Target Lesion Failure (TLF), composite of cardiac death, target vessel
Q-wave or non-Q wave Myocardial Infarction (MI), Coronary Artery Bypass
Grafting (CABG), clinically driven TLR
4. Target vessel failure (TVF), composite of cardiac death, MI and clinically
driven TVR
5. Composite of all-cause mortality and all MI
6. All serious adverse device effects (SADEs)
7. All target vessel MI*s
8. All cardiac deaths
9. Definite stent thrombosis at 1, 6, 12 months and annually up to 5 years post
procedure
10. In-segment LLL at 9 months post-procedure
11. In-stent and in-segment (proximal and distal) minimum lumen diameter (MLD)
at 9 months post-procedure
12. In-stent and in-segment binary restenosis rate angiographically assessed (*
50% diameter stenosis) at 9 months post procedure
13. In-stent and in-segment percent diameter stenosis (% DS)
IVUS Subgroup
1. Neointimal hyperplasia volume at 9 months post-procedure
2. Incomplete stent apposition
OCT Subgroup
1. Neointimal hyperplasia volume at 9 months post-procedure
2. Strut coverage at 9 months post procedure (%)
3. Stent apposition at baseline and 9 months post procedure
Background summary
Since the first Percutaneous Transluminal Coronary Angioplasty (PTCA), this
procedure has become a widely accepted treatment modality for Coronary Artery
Disease (CAD). For the majority of CAD, treatment with PTCA provides high
initial procedural success, symptomatic relief, improvement in functional
capacity, and survival rates quite similar to those of Coronary Artery Bypass
Grafting (CABG). However, all percutaneous techniques, regardless of the mode
of intervention, have rather high rates of repeat interventions at long-term
follow up. The first type of stent used in Percutaneous Coronary Intervention
(PCI), were Bare Metal Stents (BMS), designed to address the limitations of
PTCA. BMS reduced the angiographic and clinical restenosis rates in de novo
lesions compared to PTCA alone and decreased the need for CABG. BMS
substantially reduced the incidence of abrupt artery closure, but restenosis
occurred in about 20%-40% of all cases, necessitating repeat procedures. The
invention of Drug Eluting Stents (DES) significantly improved on the principle
of BMS by adding an antiproliferative drug, which is either directly
immobilised on the stent surface or released from a polymer matrix to inhibit
neointimal hyperplasia. This allows for controlled release of the drug at the
site of injury. The polymer drug carriers currently used on DES are either
biodegradable or non-biodegradable. Non-biodegradable polymers reside on the
surface of the stent indefinitely. In contrast biodegradable polymers dissolve
after a certain period of time, leaving only the BMS platform in the vessel
wall.
The introduction of DES greatly reduced the incidence of restenosis and
resulted in a better safety profile as compared to BMS with systemic drug
administration. These advantages and a lower cost compared to surgical
interventions has made DES an attractive option to treat coronary artery
disease.
This study will collect data prospectively on subjects that are randomly
assigned to be implanted with either the BIOTRONIK Orsiro or the Abbott Xience
Prime* stent. Both investigation devices have received the CE mark and are
available on the market. By comparing two different products of the latest
generation, we expect to gain more knowledge on the safety and efficacy of the
Orsiro stent vs. the *Golden Standard* Xience Prime* stent. In addition, OCT
and IVUS subgroup analyses will be performed. Taken together this will
contribute to expand the knowledge of drug eluting stents in interventional
cardiology. The built evidence through this study may also provide useful
insights for the continuous development of drug eluting stents.
Study objective
To compare the BIOTRONIK Orsiro Limus Eluting Stent System (LESS) with the
Abbott Xience Prime* Llimus Eluting Stent System (LESS) with respect to
in-stent Late Lumen Loss (LLL) in a non-inferiority study in de novo coronary
lesions at 9 months.
Study design
A prospective, multicenter, international, two-arm, non-inferiority, randomised
controlled clinical study enrolling up to 440 subjects. All subjects will be
randomised 2:1 to receive the BIOTRONIK Orsiro LESS or the Abbott Xience Prime*
LESS. The randomisation will be stratified for diabetes.
Clinical follow up visits will take place at 1, 6 and 12 months and annually
for 5 years post procedure. At 9 months all subjects will undergo an
angiographic follow up to assess the in-stent LLL.
Up to 60 pre-specified subjects will have an additional IntraVascular
UltraSound (IVUS) examination at both baseline and at the 9 months follow up
visit.
Up to 60 pre-specified subjects will have an additional Optical Coherence
Tomography (OCT) examination at both baseline and at the 9 month follow up
visit.
A subgroup subject will only be allocated to either IVUS or OCT. Both IVUS and
OCT will be conducted exclusively at pre-specified centres according to a
pre-specified allocation scheme.
This study is designed to be performed in accordance with the Declaration of
Helsinki, ISO 14155:2011(E), ICH-GCP, Local and National Regulations.
Study burden and risks
Risks
Both devices in this study have received the CE mark. Implantation of the
devices will therefore not bring additional risk to the subjects, compared to
treatment with any other drug eluting stent in standard clinical care. The
anticipated adverse events in this study are those related to regular
percutaneous interventions (PCI), with drug eluting stents. A complete
description of the risks of implantation and correct usage of the Orsiro and
the Xience Prime stents are described in each device Instructions for Use.
The additional Angiography and OCT/IVUS* FUP do provide extra risk for the
patient in terms of risk for complications and an additional radiation dose.
The direct benefit for the patient is the chance for detection and pro-active
treatment of a possible lesion and/or re-stenosis and thereby preventing a more
serious event at a later stage.
*If medically indicated both IVUS and OCT are performed during PCI procedures
in routine practice.
ECG*s will be required at screening and prior to discharge and one additional
blooddraw may be taken prior to the angiographic follow up at 9 months post
procedure.
Taken together, all subjects will have a more intense medical follow up then in
standard practice, which may be beneficial to the long term clinical outcome
for the individual.
Ackerstrasse 6
8081
CH
Ackerstrasse 6
8081
CH
Listed location countries
Age
Inclusion criteria
1.Subject has provided a written informed consent
2.Subject is * 18 years and * 80 years old
3.Single de novo lesion with * 50% and <100% stenosis in up to 2 coronary arteries
4.Subject, target vessel(s) and lesion(s) are eligible for PCI with the Orsiro stent
5.The target lesion length is * 26 mm (assessed either visually or by online Quantitative Coronary Angiography (QCA)) and can be covered by one study stent
6.The target reference vessel diameter is * 2.25 mm and * 4.0 mm (assessed either visually or by online QCA)
7.Target vessel(s) TIMI flow * 2
8.Subject is an acceptable candidate for CABG
9.Clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia
10. Eligible for Dual Anti Platelet Therapy (DAPT) treatment with Acetylsalicylic Acid (ASA) plus either, Clopidogrel, Prasugrel, Ticlopidine or Ticagrelor
Exclusion criteria
1.Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
2.Evidence of myocardial infarction within 72 hours prior to index procedure
3.Subjects with CK, CKMB(optional) and/or Troponin levels exceeding the normal range within 24 hours prior to the procedure
4.Unprotected left main coronary artery disease (stenosis >50%)
5.Three-vessel coronary artery disease at time of procedure
6.Thrombus in target vessel
7.Planned interventional treatment of any non-target vessel within 30 days post-procedure
8.Planned intervention of the target vessel after the index procedure
9.Ostial target lesion (within 5.0 mm of vessel origin)
10.Target lesion involves a side branch > 2.0 mm in diameter
11.Documented left ventricular ejection fraction (LVEF) * 30%
12.Heavily calcified lesion
13.Target lesion is located in or supplied by an arterial or venous bypass graft
14.The target lesion requires treatment with a device other than the pre-dilatation balloon prior to stent placement (including but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, cutting balloon etc.)
15.Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, Everolimus or similar drugs (i.e., ABT 578, Biolimus,Tacrolimus); CoCr, PLLA, Silicon Carbide
16.Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
17.Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
18.Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off
19.Life expectancy less than 1 year
20.Planned surgery or dental surgical procedure within 6 months after index procedure
21.In the investigators opinion subject will not be able to comply with the follow-up requirements
22.Subject is currently participating in another study and has not reached the primary endpoint
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01356888 |
| CCMO | NL36465.100.11 |