The COMBO HEALING evaluates the long term healing pattern of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) in routine clinical practice. The primary objective of the study is to the asses the long…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For all analyses the findings at each individual timepoint and the * between
timepoints will be assesed
- OCT findings on strut coverage (binary and thickness), neointimal morphology,
strut malapposition, incidence of intracoronary thrombi and late loss (late
tissue growth, plaque volume, lumen cross sectional area).
- Quantitative Coronary Angiography analyses of minimal lumen diameter, mean
lumen diameter, maximum percent stenosis, mean stenosis and late lumen loss.
Secondary outcome
Not applicable
Background summary
The implantation of bare-metal stents (BMS) has significantly reduced clinical
and angiographic restenosis compared to balloon angioplasty alone after PCI due
to eliminating elastic recoil and reducing arterial remodeling. However,
in-stent restenosis still occurred frequently after BMS implantation in 20% to
40% of patients due to neointimal proliferation. The development, clinical
validation and widespread use of drug-eluting stents (DES) have revolutionized
the treatment of patients with coronary artery disease. Large-scale,
prospective, multicenter double-blind randomized trials have provided strong
evidence that drug-eluting stents significantly reduce angiographic restenosis
and enhance event-free survival compared with BMS after implantation in native
coronary arteries (1-4). However, despite an improved efficacy in the
prevention of restenosis and target vessel failure safety concerns have been
raised for DES, focusing on a small but clinically important increase in stent
thrombosis occurring greater than one year after the index procedure (5-11).
In patients receiving drug-eluting stents, the diagnosis of acute coronary
syndrome has been identified as one of the major risk factors of stent
thrombosis (8). Therefore, concerns about the long-term outcome and safety
after drug-eluting stent implantation due to late stent thrombosis and late
stent malapposition have been raised (11).
Stent thrombosis, in particular late and very late stent thrombosis, has been
related to an impaired stent healing, most of all to a reduced endothelial
repair, i.e. reduced stent strut coverage, after implantation of drug-eluting
stents (8). This has resulted in the recommendation of a prolonged 12-month
dual antiplatelet therapy with aspirin and clopidogrel after drug-eluting stent
implantation (9), however, how long dual antiplatelet therapy is needed is
unknown at present. These observations have resulted in an intense search for
alternative strategies to promote stent healing and endothelial repair, rather
than the inhibition of endothelialisation of the stent, that is common to the
substances used to prevent neointima formation.
Notably, endothelial repair can be substantially enhanced by CD34+ endothelial
progenitor cells. In order to simultaneously promote endothelial and prevent
neointima formation and restenosis, the Combo stent is covered with a CD34+
antibody to attract endothelial progenitor cells, and on the abluminal side
releases sirolimus. Several preclinical studies in the porcine coronary artery
model have shown, that endothelialisation and stent healing are accelerated in
the Combo stent (12;13).
Previous studies have indicated that Combo stent placement is safe and
feasible. The present study has been designed to evaluate the long-term healing
pattern of the Combo stent. Vascular healing and enhanced stent strut coverage
is expected to improve by the Combo stent technique. The current study aims to
provide vital data on these parameters in human subjects at long-term
follow-up.
Study objective
The COMBO HEALING evaluates the long term healing pattern of the Abluminal
Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting
Stent) in routine clinical practice. The primary objective of the study is to
the asses the long-term healing pattern after Combo stent placement by Optical
Coherence Tomography (OCT).
Study design
The COMBO HEALING is an international, prospective, multi-centre, longitudinal
study for the assessment of the long-term healing pattern of the Combo
Bio-Engineered Sirolimus Eluting Stent with intravascular imaging by means of
OCT. The study involves two reangiographies with OCT up to five years after
index procedure in a randomly selected cohort of patients treated with one or
more Combo stents.
Study burden and risks
Patients will undergo an OCT pullback during coronairy angiography. To allow
this pullback a wire will be placed in the coronary artery. The riskof a wire
is a dissection of the coronary artery or spasm of the artery. This occurs in
2-3% of the patients (1:1000). These complications occur mostly in patients
known with severe cardiac conditions, we expect no severe complications in our
study given the fact that we will not include patients with severe cardiac
illnesses. After coronary angiography there is also a small risk of bleeding,
especially at the access site of the guiding catheter (wrist or groin).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1. The patient must be *18 and * 80 years of age;
2. Device and procedural success at the index procedure;
3. The Patient is willing to comply with specified follow-up evaluations;
4. The Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC).
Exclusion criteria
1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
2. Impaired renal function (serum creatinine >2.0 mg/dL or 177 *mol/l) or on dialysis;
3. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC<3,000 cells/mm3;
4. Patient has other medical illness (e.g., cancer, known malignancy, or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with
5. a limited life expectancy (i.e., less than 1 year);
6. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus, everolimus and/or contrast sensitivity that cannot be adequately pre-medicated;
7. Patient has received any organ transplant or is on a waiting list for any organ transplant;
8. Any significant medical condition, which in the Investigator*s opinion may interfere with the patient*s optimal participation in the study;
9. Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up;;Angiographic exclusion criteria
10. Patients treated for in-stent restenosis of the index procedure Combo stent during follow-up;
11. Patients treated for in-segment stenosis of the index procedure Combo stent during follow-up;
12. Patients treated for a bifurcation lesion with a 2 stent strategy at the index procedure during follow-up;
13. Patients treated in a bypass graft at the index procedure;
14. Patients with >1 overlapping Combo stent at the index procedure;
15. Patient with unsuitable anatomy for OCT (tortious, heavily calcified, small distal stent).
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 |
|---|---|
| CCMO | NL50520.018.14 |