The primary objective of this study is to evaluate the safety and effectiveness of the Genous Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin), in the treatment of elective patients with up to two de novo…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint
The primary endpoint of this study is in-stent late loss at 6 months by
Quantitative Coronary Angiography (QCA).
Secondary outcome
- Angiographic success
- Procedure success
- Angiographic and/or clinical stent thrombosis
- In-stent late loss at 18 months
- Binary restenosis rate at 6 and 18 months
- In-segment late loss at 6 and 18 months
- Volumetric assessment (derived from QCA parameters) at 6 and 18 months
- Circulating endothelial progenitor cell (EPC) count at screening, index
procedure and at 30 days.
- Target Vessel Failure (TVF) at 30 days, 6, 12, 18 months and at 2, 3, 4 and 5
years
- Major adverse cardiac events (MACE) at 30 days, 6, 12, 18 months and at 2, 3,
4 and 5 years
- Clinically-driven Target Lesion Revascularization (TLR) free rate at 30 days,
6, 12 and 18 months and at 2, 3, 4 and 5 years
- Protocol related serious adverse events (SAEs) up to 5 years
- Change in human anti-murine antibody (HAMA) plasma levels at 1 and 6 months
follow-up as compared to baseline.
Background summary
By recruiting the patient*s own EPCs to the site of vascular injury (e.g. the
site of a coronary stent implant), an acceleration of the normal
endothelialization process would occur. It is further theorized that the rapid
establishment of a functioning endothelial layer may promote the transformation
of the injured site to a healthy state. For example, in the case of coronary
stent implantation, rapid re-endothelialization may reduce inflammation,
thrombosis and potentially eliminate restenosis.
Patients are asked to take 80 mg of Atorvastatin two weeks prior to the
procedure up to six weeks post-procedure to increase the EPC in the blood.
Study objective
The primary objective of this study is to evaluate the safety and effectiveness
of the Genous Bio-engineered R stentTM in conjunction with optimal statin
therapy (80mg of atorvastatin), in the treatment of elective patients with up
to two de novo native coronary artery lesions.
Study design
This is a multi-center, prospective, non-randomized study. Approximately 90
patients from up to 16 centers will be entered in the study.
Patients will be followed clinically for up to 5 years post-procedure. All
patients will have a repeat angiography at 6 and 18 months follow-up.
Intervention
Patient will receive a stent implantation according to the hospital practice.
After implantation the usual follow up and monitoring wil be performed
Study burden and risks
- The formation of a blood clot that would partially or totally block the blood
flow (3-5%)
- Death (1.5%)
- A bleeding that requires surgery (5.6%) or blood transfusion (5.4%)
- Standard medication that you will receive (aspirin and clopidogrel) Aspirin
may increase the likelihood of gastrointestinal adverse effects and bleeding.
Clopidogrel is uncommonly associated with rash, diarrhea, nausea, vomiting,
stomach pain, an increase in cholesterol levels, a drop in the number of white
blood cells (which could lead to an increased risk of infection), or a drop in
the number of platelets (which could lead to an increased risk of bleeding).
- The use of atorvastatin may increase the likelihood of gastrointestinal
adverse effects, muscular pain and impairment of liver function.
- The Genous stent, has a special surface which allows this stent to capture
your EPCs. The surface contains a minute quantity of an animal protein. You
may have an immune reaction to this surface which may result in allergic type
reactions. If this occurs, there is a risk that future treatment with a
monoclonal antibody may be compromised.
- Although very unlikely, there may be unforeseeable risks that are not known
at this time. There is always the risk that you may require another
intervention or coronary by-pass surgery.
Paleisstraat 24
2018 Antwerpen
Belgie
Paleisstraat 24
2018 Antwerpen
Belgie
Listed location countries
Age
Inclusion criteria
-Treatment of 1 or 2 de novo lesions;
-Target lesion(s) is(are) located in a native coronary artery, which can be covered by one single stent of maximum 33 mm;
- Reference vessel diameter min.2.5 and max.3.75 mm by visual estimate;
- Target lesion stenosis is >50% and <100%;
- The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent.
Exclusion criteria
- A Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes or Troponin levels are less than twice the Upper Normal Limit;
- Documented or suspected liver disease;
- Recipient of heart transplant;
- Known allergies to aspirin, clopidogrel bisulphate and ticlopidine, heparin, or stainless steel;
- Any patient who previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-mouse Antibodies (HAMA).
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 |
|---|---|
| EudraCT | EUCTR2006-006481-42-NL |
| CCMO | NL13206.078.06 |