Evaluation of provisional T stenting using a bare metal stent in combination with a paclitaxel eluting balloon compared with a normal balloon. And comparing a bare metal stent in combination with a paclitaxel eluting balloon with a paclitaxel elutin…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Angiographic evaluation of reduction of vessel diameter at 6 months follow-up
at the treated segments ( incidence of late Lumen Loss )
Secondary outcome
*Target vessel failure* at 6 months follow up.
The incidence of Major Adverse Coronary or Cerebral events ( MACCE ) at 6
month follow up.
Background summary
Within the field of Percutaneous Coronary Interventions the treatment of
bifurcation lesions remains challenging. Not only regarding - acute- technical
outcomes but also
long term results regarding an increased risk for restenosis and with the
widespread use of DES a higher chance of late stent thrombosis and maybe even
higher late mortality.
With the introduction of Drug Eluting Balloons there is the potentially
interesting option not only to change the technique ( only provisional stenting
) but also influencing long term results because the use of only one stented
segment reduces complexcity of the procedure. Without using multiple DES the
risk of subacute stent thrombosis is also lower and therefore need for
prolonged ( livelong ? ) dual antiplatelet therapy is reduced.
Recently the Dior balloon was CE approved , a paclitaxel coated balloon which
showed a remarkebly efficacy in reducing restenosis in patients with in stent
restenosis .
(Scheller et al, Treatment of coronary in-stent restenosis with a
paclitaxel-coated balloon catheter; New England Journal of Medicine 2006 Nov 16
2149-51).
The study question will be if the incidence of restenosis in bifurcation
lesions will be reduced also when using this balloon, without a higher risk of
late thrombosis.
Study objective
Evaluation of provisional T stenting using a bare metal stent in combination
with a paclitaxel eluting balloon compared with a normal balloon. And comparing
a bare metal stent in combination with a paclitaxel eluting balloon with a
paclitaxel elutin gstent in combination with a normal balloon.
Study design
Randomised prospective study with 3 arms.
Intervention
Comparison of three groups :
Group A : normal bare metal stent with normal balloons
Group B: normal bare metal stent with paclitaxel balloons
Group C: paclitaxel eluting stent with normal balloons
Study burden and risks
Patients will undergo a standard PCI treatment with the difference that group B
will see the use of a paclitaxel eluting balloon in stead of a normal balloon.
Systemical side effects of local drug delivery within the artery wall are not
to be expected.
Furthermore a 6 month angiografical follow up is required for which informed
consent is obtained.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
- stable angina pectoris or unstable angina and documented ischemia or silent ischemia.
- the target lesion has a major native coronary artery (>2.5 mm) with a stenosis > 50% (on visual assessment) located at a side branch (>2 mm).
- de novo lesion
Exclusion criteria
- in stent restenosis of target lesion
- severe calcifications with an undilatable lesion during balloon predilatation (PTRA could be considered)
- untreated significant lesion greater than 50% diameter stenosis remaining proximal of distal to the target intervention.
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 | NL18672.041.07 |