To evaluate the safety and performance of the Paclitaxel Eluting Balloon Balloon mounted with a Cobalt Chromium stent (DEBS) and Paclitaxel Eluting Balloon (DEB) in patients with de novo coronary artery disease.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the safety of the Paclitaxel Eluting Balloon (DEB) and Paclitaxel
Eluting Balloon stent (DEBS) in patients with de novo coronary artery lesions
by composite of Major Adverse Cardiac Event (MACE) rate at 6 months which must
be <12%. MACE is defined as cardiac death, MI (Q-wave and non-Q-wave) and
clinically driven target lesion revascularization (PCI and CABG)
Secondary outcome
1. Device Success: The ability of the Drug Eluting Balloon (DEB) to be
delivered at the target lesion , to be able to dilate and retrieve the system
or, the ability of the Drug Eluting Balloon Stent (DEBS) to be delivered at the
target lesion, to be able to deploy the stent and retrieve the delivery system.
2. Lesion treatment success is defined as <50% residual stenosis measured by
quantitative coronary angiography (QCA.)
3. Procedure success defined as lesion success without the occurrence of MACE
during the hospital stay.
4. MACE rate at 1 month and 1 and 2 year follow up. MACE is defined as cardiac
death, MI (Q-wave and non-Q wave) and clinically driven target lesion
revascularization (PCI and CABG)
5. Target lesion revascularization (TLR) at 1 and 6 months and 1 and 2 year
follow up.
6. Target vessel revascularization (TVR) at 1 and 6 months and 1 and 2 year
follow up.
7. Late Lumen Loss (LLL) at 6 months follow up
8. Binary in-segment restenosis at 6 months follow up
9. Stent thrombosis up to 2 year follow up
Background summary
The development of drug eluting stents (DES) have been very successful in
reducing the rate of acute re-interventions and repeated revascularization
procedures at follow up as compared to simple balloon angioplasty. However,
important drawbacks of stents versus balloons remain.
First, flexibility and deliverability of the stent platform might be a limiting
factor in successful delivery of the device. Indeed, improvements in the stent
design continuously allow for the treatment of more complex lesions.
Second, implantation of stents reduces the flexibility of the vessel and limits
the repeatability of the procedure.
Third, although in-stent restenosis rates have already dropped significantly
over the last decade, repeated revascularization procedure still occurs.
Neointimal hyperplasia is the main factor responsible for this phenomenon. The
time course of this event in humans commonly occurs during the first 6 months
after deployment. The degree of the in-stent hyperplasia is influenced by
procedural and anatomical and physiological factors. Adding neointimal
inhibiting medication directly to the stent surface using a coating technique
has been largely evaluated in the last decade.
Fourth, since stents are foreign objects, they are prone to create intraluminal
thrombosis. Furthermore, addition of neointimal inhibiting drugs on the stents
can further limit the re-endothelialization and healing process around the
stent surface, increasing the risk of problems related to the occurrence of
subacute and late stent thrombosis. This also implies that long-lasting
anti-platelet therapy is required to avoid late thrombotic complications.
To overcome the possible problems with long term toxicity of the used drugs on
these DES types, new efforts are made to develop new ways to deliver the drugs
on the treated vessel wall, in order to further improve the acute and long term
outcomes of percutaneous coronary interventions.
Drug-coated balloons may represent an alternative option for treatment of both
de-novo and in-stent restenotic lesions.
In this study the safety and efficacy of the Paclitaxel Eluting Balloon and
Paclitaxel Eluting Balloon stent will be evaluated in patients with de-novo
lesions in native coronary vessels.
Study objective
To evaluate the safety and performance of the Paclitaxel Eluting Balloon
Balloon mounted with a Cobalt Chromium stent (DEBS) and Paclitaxel Eluting
Balloon (DEB) in patients with de novo coronary artery disease.
Study design
Prospective, Multicentre, Single arm, Non-Inferiority Clinical Trial
Intervention
Patients are treated by a PTCA procedure where a Paclitaxel Eluting Balloon
mounted with a Cobalt Chromium stent (DEBS) and/or Paclitaxel Eluting Balloon
(DEB) is used to treat stenotic lesions.
Which device (DEB or DEBS) is used is on the insight of the treating physician.
Study burden and risks
The occurrence of the complications listed in the adverse event section of the
protocol may lead to the need for a repeat catheterization and/or percutaneous
intervention, myocardial infarction, emergency bypass surgery, or death. Since
the Paclitaxel Eluting Balloon or Paclitaxel Eluting Balloon with Stent are
investigational devices, all of the risks associated with its usage are not
entirely known, but are believed to be similar to those that are associated
with current clinical practices using (drug-eluting) balloons and stents to
treat the coronary arteries. Treatment may involve some additional risks to the
study patient, the natures of which are not known.
Steenovenweg 19
5708HN HELMOND
NL
Steenovenweg 19
5708HN HELMOND
NL
Listed location countries
Age
Inclusion criteria
1. Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia
2. Patients who are eligible for coronary revascularization (percutaneous angioplasty and/or CABG).
3. Patients with up to two de novo lesion in a native coronary artery >50% and <100% stenosis.
4. Reference diameter between 2.0mm and 4.0mm and maximum lesion length of 26mm
5. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.
Exclusion criteria
1. Patients under the age of 18 or unable to give informed consent.
2. Women who are pregnant. Women of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable contraception at a minimum until after the angiographic follow up.
3. Patients who previously participated in this study.
4. Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
5. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.).
6. Patients treated with drug eluting stent(s) in the target vessel less than 12 months prior to the index procedure
7. Patients with a previous stent in the target lesion (in-stent Restenosis)
8. Patients with angiographic evidence of severe calcification of the target lesion.
9. Angiographic evidence of presence of thrombus in the target vessel
10. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
11. Patients with recent (<= 48 hours) myocardial infarction.
12. Patients with a contraindication to an emergent coronary bypass surgery.
13. Any individual who may refuse a blood transfusion.
14. Severe renal insufficiency (creatinine > 160 *mol/L or maximum flow declination rate (GFR < 50 ml/min).
15. Patients with intolerance or contraindication to the required medication (heparin, aspirin, clopidogrel and prasugrel, Paclitaxel).
16. Patients with contrast agent hypersensitivity that cannot be adequately pre-medicated.
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 | NL31913.060.10 |