To prospectively collect and assess global safety and efficacy data on the IN.PACT Admiral* Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease of the superficial femoral and/or popliteal arteries in *real world* patient population.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A composite of freedom from device- and procedure-related mortality through 30
days, freedom from major target limb amputation and TLR within 12 months
post-index procedure.
Secondary outcome
Clinical Cohort:
1. MAEas at 30 days, 6, 12, 24, 36, 48 and 60 months.
a MAE is defined as all-cause mortality, clinically-driven TVR, major
target limb amputation, thrombosis at the target lesion site.
2. All-cause mortality at 30 days, 6, 12, 24, 36, 48 and 60 months.
3. Clinically-driven TLR at 30 days, 6, 24, 36, 48 and 60 months.
4. Clinically-driven TVRb at 30 days, 6, 12, 24, 36, 48 and 60 months.
b Clinically-driven TVR is defined as any re-intervention within the target
vessel due to symptoms or drop of ABI of >= 20% or > 0.15 when
compared to post-index procedure baseline ABI.
5. TLR at 6, 12, 24, 36, 48 and 60 months.
6. TVR at 6, 12, 24, 36, 48 and 60 months.
7. Major target limb amputation at 30 days, 6, 12, 24, 36, 48 and 60
months.
8. Time to first clinically-driven TLR through 60 months post-index
procedure.
9. Time to all-cause mortality through 60 months post-index procedure.
10. Primary sustained clinical improvementc at 6, 12, 24, 36 months.
c Primary sustained clinical improvement is defined as sustained upward
shift of at least 1 category on Rutherford classification as compared to
baseline without the need for repeated TLR or surgical revascularization
in amputation-free surviving subjects.
11. Secondary sustained clinical improvementd at 6, 12, 24, 36 months.
d Secondary sustained clinical improvement is defined as sustained
upward shift of at least 1 category on Rutherford classification as
compared to baseline including the need for repeated TLR or surgical
revascularization in amputation-free surviving subjects.
12. Immediate hemodynamic improvemente at post-index procedure.
e Immediate hemodynamic improvement is defined as an ABI
improvement of >= 0.1 or to an ABI >= 0.9.
13. Sustained hemodynamic improvementf at 6, 12, 24, 36 months.
f Sustained hemodynamic improvement is defined as persistent
improvement of ABI-values with >= 0.1 as compared to baseline values or
to an ABI >= 0.9 throughout follow-up without the need for repeated TLR
or surgical revascularization in amputation-free surviving subjects.
14. Walking impairment evaluation by Walking Impairment Questionnaire
(WIQ) at 6, 12, 24, 36 months.
15. Walking distance as measured by 6 Minute Walk Test at 6, 12, 24, 36
months.
16. Health related Quality of life scores (EQ5D) at 6, 12, 24, 36 months.
17. Device successg
g Device success is defined as successful delivery, balloon inflation and
deflation and retrieval of the intact study device without burst below the
rated burst pressure (RBP).
18. Procedural successh
h Procedural success is defined as residual stenosis of <= 50%
(non-stented subjects) or <= 30% (stented subjects) by visual estimate.
19. Clinical successi
i Clinical success is defined as procedural success without procedural
complications (mortality, major target limb amputation, thrombosis of the
target lesion, or TVR) prior to discharge.
Imaging Cohort:
20. Duplex-defined binary restenosis (PSVR > 2.0) of the target lesion at 12
months, or at the time of re-intervention.
21. Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion at 12
months, or at the time of re-intervention.
Background summary
Peripheral artery disease (PAD) commonly results from progressive narrowing of
the arteries
in the lower extremities, usually due to atherosclerosis. In claudicant
subjects approximately
30% of the lesions are located in the iliac arteries and 70% in the
femoro-popliteal and tibial
tract; a small percentage is located in the vasculature below the knee. Risk
factors for
development of PAD include diabetes, smoking, hypertension, dyslipidemia,
increasing age
and chronic renal insufficiency. Individuals with PAD often experience
intermittent claudication,
although some may be asymptomatic. Progression of PAD can result in critical
limb ischemia
(CLI), manifested by ischemic pain at rest or in the breakdown of the skin,
resulting in ulcers or
gangrene which ultimately may lead to amputation and death.
The prevalence of PAD has been evaluated in several epidemiologic studies and
is estimated
to be in the range of 5% to 30% in adult population in industrialized
countries. Data from
the 1999-2000 National Health and Nutrition Examination Survey in the US
revealed that
PAD, defined as ABI < 0.9 in either leg, was 4.3% in adults aged 40 years and
over. This
means that about 5 million individuals are expected to have PAD. Among those
aged 70 years
or over, the prevalence was 14.5%. Other studies confirmed that the prevalence
of
PAD, using similar diagnostic criteria, ranged from 3% to 4% among middle-aged
adults and
between 13% and 14% in the elderly. The incidence and prevalence of PAD
increases
substantially with age in both males and females.
Study objective
To prospectively collect and assess global safety and efficacy data on the
IN.PACT Admiral* Drug Eluting Balloon (DEB) in treatment of atherosclerotic
disease of the superficial femoral and/or popliteal arteries in *real world*
patient population.
Study design
Prospective, multi-centre, single-arm study.
Intervention
All patients are treated with the IN.PACT Admiral* Drug Eluting Balloon
(DEB)manufactured by Medtronic. The IN.PACT Admiral* is a CE marked medical
device utilized within its intended use in the IN.PACT Global trial.
Study burden and risks
Based on our current knowledge, participation into the IN.PACT Global Clinical
Study
does not impose additional risks. There is a high probability that subjects
benefit when using a
DEB as several studies have shown clinical and angiographical superiority when
compared to
standard PTA. The potential benefits of the study outweigh the potential risks;
therefore the
investigation is justified. It is possible in any clinical trial that harmful
things can happen which
are not known at this time. All efforts will be made to minimize the risks in
this study by
selecting investigators who are experienced and trained in the use of the study
device and
trained to the study protocol, by clearly defining inclusion/exclusion criteria
to ensure only
appropriate subjects are enrolled, and by ensuring that treatment and follow-up
of the subject
are consistent with current medical practices.
Due to the low dosage and local administration of paclitaxel, drug reactions
have not been
reported and are not to be expected.
Endepolsdomein 5
Maastricht 6629 GW
NL
Endepolsdomein 5
Maastricht 6629 GW
NL
Listed location countries
Age
Inclusion criteria
* Age >= 18 years or minimum age as required by local regulations.
* Subject with documented diagnosis of peripheral arterial disease (PAD) in
the superficial femoral artery (SFA) and/or popliteal artery (PA) (including
P1, P2, P3) classified as Rutherford class 2-3-4.
* Angiographically documented single or multiple lesions/occlusions (de
novo or re-stenotic lesion(s) or in-stent restenosis) within the target
vessels with a minimum lesion length of 2 cm including bilateral disease if
both limbs are treated within 35 days.
* Positive diagnostic indication for PTA with a DEB in accordance with the
Instructions For Use (IFU) of the IN.PACT Admiral* DEB.
* Adequate distal run-off to the ankle (at least one native calf vessel
[posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as
<= 50% diameter stenosis) either pre-existing or successfully reestablished
prior to target lesion treatment.
* Adequate inflow (<= 50% diameter stenosis) either pre-existing or
successfully re-established prior to target lesion treatment.
* Female subjects of childbearing potential must have a negative
pregnancy test <= 7 days before enrollment.
* Signed and dated Patient Informed Consent (PIC) form.
* Ability and willingness to comply with the clinical investigation plan (CIP).
* Life expectancy, in the Investigator*s opinion, of at least 12 months.
Exclusion criteria
* High probability of non-adherence to CIP follow-up requirements.
* Failure to successfully cross the target lesion with a guide wire
(successful crossing means tip of the guide wire distal to the target lesion
in the absence of flow limiting dissections or perforations).
* Lesion within or adjacent to an aneurysm or presence of a popliteal
aneurysm.
* Acute or sub-acute thrombus in the target vessel.
* Previous bypass surgery to the target lesion.
* Target lesion also requires treatment with alternative therapy such as
drug-eluting stent (DES), laser, atherectomy, cryoplasty, cutting/scoring
balloon, brachytherapy.
* Plan for surgical or interventional procedure within 30 days after the study
procedure (except for bilateral target limb treatment).
* Known allergies or sensitivities to heparin, aspirin, other anticoagulant/
anti-platelet therapies, and/or paclitaxel.
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 |
|---|---|
| ClinicalTrials.gov | NCT01609296 |
| CCMO | NL40343.100.12 |