ObjectiveTo investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be primary patency of the treated site at 6 months.
Primary patency is defined as <50% loss of luminal diameter at the treated site
on CT arteriography (CTA) without re-intervention in the interim.
Secondary outcome
* Primary patency at duplex (psv ratio <2.0) of the treated sites at discharge,
3, 6 and 12 months after intervention.
* Clinical categorisation of the treated ischemic leg by means of the
Rutherford classification at 3, 6 and 12 months, 2, 3, 4 and 5 years.
* Major amputation (at or above the ankle) of the trial leg at 3, 6 and 12
months, 2, 3, 4 and 5 years.
* Minor amputation (below the ankle excluding the toes) of the trial leg at 3,
6 and 12 months, 2, 3, 4 and 5 years.
* Infrapopliteal surgical bypass of the trial leg at 3, 6 and 12 months, 2, 3,
4 and 5 years.
* Infrapopliteal endovascular re-intervention of the trial leg at 3, 6 and 12
months, 2, 3, 4 and 5 years
* Patency of treated femoropopliteal sites, if applicable.
* Peri-procedural (within 30 days) complications.
* Death.
After 5 years only surveillance (medical records) of survival and amputation
will be performed until 10 years after initial treatment.
Background summary
Title
PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb
Ischemia
(PADI)
Study objective
Objective
To investigate the performance of paclitaxel-coated balloon expandable
stainless
steel coronary stent for the treatment of infrapopliteal stenoses and
occlusions in
patients with critical limb ischemia compared to percutaneous transluminal
balloon
angioplasty (PTA).
Study design
Study design
Multi-center, prospective, randomised, two-arm study. Patients will be
randomised on a 1:1 basis. It is anticipated that a total of 136 patients will
be entered in the study. Subjects will be followed for 12 months after
treatment. Study examinations will be performed at screening, during
intervention, at discharge and after 3, 6 and 12 months, 2, 3, 4 and 5 years.
The trial will be performed at 3 investigation centres in the Netherlands.
Intervention
Participants will be randomised to PTA or PTA plus drug eluting stent placement
Study burden and risks
Safety parameters
The safety outcome of the trial will be described in terms of the incidence of
procedure or stent related serious adverse events in the 12-month period after
stent implantation. After the first 40 patients have been randomised (20 for
stent placement) there will be an interim analysis for safety. This interim
analysis will focus on acute thrombosis within 6 weeks after implantation. The
expected percentage of thrombosis is less than 10%. If in the first 40 patients
the acute thrombosis is 20% higher in either the stent group compared to the
balloon angioplasty group or visa versa, which is a difference of more than 4
patients, the study will be temporarily stopped to analyse these findings. The
METC will be informed and a new approval from the METC will be required to
restart the study
Randomisation into the stent-group will not produce a significant burden
compared to PTA alone. Procedure length will be only slightly longer in this
group. Subjects in both groups will be prescribed a daily dose of 100mg
acetylsalicylic acid indefinitely and a daily dose of 75mg clopidogrel for 6
months.
Burden to the patient resulting from participation in this study consists of 7
follow-up visits to the vascular surgeon and the radiology department for
clinical follow-up and duplex sonography and 1 CTA examination (with injection
of IV contrast medium) at 6 months. The follow-up visits are at 3, 6 and 12
months, 2, 3, 4 and 5 years after primary intervention. Data of patients
undergoing major amputation of the target limb during follow-up will be
passively acquired, they will not be invited for hospital visits. Of these
patients only survival will be monitored.
After 5 years, all patient will passively surveilled for survival and
amputation up to 10 years after initial treatment.
Pettelaarpark 33, Postbus 1988
5200 BZ 's Hertogenbosch
NL
Pettelaarpark 33, Postbus 1988
5200 BZ 's Hertogenbosch
NL
Listed location countries
Age
Inclusion criteria
Critical limb ischemia as a result of obstruction/occlusion of infrapopliteal (below-the-knee) arteries
Exclusion criteria
Acute limb ischemia
Absence of sufficient inflow to infrapoliteal arteries
Allergy to contrast media, heparin, acetylsalicylic acid or paclitaxel
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 | NCT00471289 |
| CCMO | NL15134.098.08 |