1. Evaluate safety and clinical and angiographic efficacy of BTK revascularization with IN.PACT Amphirion* randomized to standard, uncoated PTA balloons2. Assess the clinical efficacy of BTK revascularization with IN.PACT Amphirion* compared to a…
ID
Source
Brief title
Treat critical ischemia btk with Drug Eluting Balloon
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. For the Angio-cohort: late lumen loss (LLL) of the target lesion as assessed
by quantitative vascular angiography (QVA) either at 12 months or at a time of
a Target Lesion Revascularization (TLR).
2. For all patients: cumulative *clinically driven* TLR of the target lesion in
the (major) amputation free surviving patients at 12 months.
*Clinically driven TLR* is defined as any TLR of the target lesion associated
with:
a. Deterioration of Rutherford Class and / or
b. Increase in size of pre-existing wounds and / or
c. Occurrence of a new wound(s)
with options b. and c. as adjudicated by the wound healing core lab.
3. Composite of all cause death, major amputation and clinically driven TLR at
6 months
Secondary outcome
1. Amputation free survival at 30 days, 3 and 6 months, 1, 2, 3, 4 and 5 years
2. Rate of wound healing at 30 days, 6 months, 1 and 2 years
3. Amputation free survival and wound healing at 6 months, 1 and 2 years
4. Amputation free survival and resolved CLI at 6 months, 1 and 2 years
5. Death, amputation and clinically driven TLR at 30 days, 6 months, 1 and 2
years
6. Primary sustained clinical improvement: an improvement shift in the
Rutherford classification of one class in amputation free, clinically driven
TLR free surviving patients at 1 year
7. Secondary sustained clinical improvement: an improvement shift in the
Rutherford classification of one class including the need for clinically driven
TLR in amputation free surviving patients at 1 year
8. Quality of life assessment by EQ5D (EuroQol 5 Dimensions) at 6 months, 1,
and 2 years vs. baseline
9. Walking capacity assessment by WIQ at 6 months, 1, and 2 years
10. MAE (Major Adverse Events) at 30 days, 6 months, 1, 2, 3, 4, 5 years (for
definition refer to section 14 Terms & Definitons)
11. Device Success defined as exact deployment of the device according to the
instructions for use as documented with suitable imaging modalities and in case
of digital subtraction angiography, in at least 2 different imaging projections
12. Technical Success defined as successful vascular access and completion of
the endovascular procedure and immediate morphological success with <= 50%
residual diameter reduction of the treated lesion on completion angiography
13. Procedural Success defined as combination of technical success, device
success and absence of procedural complications
14. For the Angio-cohort: improvement in 12 month % diameter stenosis (%DS) of
the TL assessed by Quantitative Vascular Angiography (QVA)
15. Days of hospitalization
Background summary
The social and economic burden of CLI is enormous and its growth on a global
basis, remain unceasing. It is estimated that between 220,000 to 240,000 major
and minor lower extremity amputations are performed in the United States and
Europe yearly due to CLI. Historically, the gold standard for treatment of CLI
has been surgical revascularization. However, this approach is limited to
subjects with good distal target vessels and lack of severe comorbid condition
as advanced age and several co-morbidities, such as diabetes and coronary
artery disease, have shown to increase the surgical risk. Objective advantages
of PTA vs surgery are related to a lower procedural morbidity and mortality,
reduced costs, faster procedural time and shorter hospital stay. Several
pre-clinical and clinical trials, both in coronary and peripheral indications,
have already been published showing safety and efficacy of paclitaxel eluting
balloon catheters.
Study objective
1. Evaluate safety and clinical and angiographic efficacy of BTK
revascularization with IN.PACT Amphirion* randomized to standard, uncoated PTA
balloons
2. Assess the clinical efficacy of BTK revascularization with IN.PACT
Amphirion* compared to a Performance Goal (PG) of 12 month Amputation Free
Survival (AFS) derived from the surgical literature.
Study design
Prospective, multi-center, randomized (2:1) study of BTK balloon angioplasty
with the IN.PACT Amphirion* vs standard non-coated balloons (control arm).
Following a double randomization scheme (see page 20), patients will be
assigned to either angiographic follow up (Angio-cohort) and clinical follow up
or sole clinical follow up, based on the target lesion presentation
Intervention
BTK revascularization with IN.PACT Amphirion* randomized to standard, uncoated
PTA balloons
Study burden and risks
There is no or only a minimal additional burden as this patient population (CLI
patients) needs to return to the hospital quite frequently. Even if some
patients are required to undergo a re-angio at 1 year it is expected that a lot
of patients need to come back for a re-PTA even earlier (primary patency at 1
year in this patient population is approx. 50%)
Endepolsdomein 5
Maastricht 6229GW
NL
Endepolsdomein 5
Maastricht 6229GW
NL
Listed location countries
Age
Inclusion criteria
-Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6
-Life expectancy >1 year in the Investigator*s opinion
-Reference vessel(s) diameter between 2 and 4 mm
-Single or multiple lesions with >=70% DS of different lengths in one or more main afferent crural vessels including the tibioperoneal trunk
-Angio-TL is one identifiable single solitary or series of multiple adjacent lesions with a DS >=70% and a cumulative length <=100 mm that can be covered by a single IN.PACT Amphirion* (10 mm balloon landing zone in both edges is mandatory)
Exclusion criteria
-Planned major index limb amputation
-Lesion and / or occlusions located or extending in the popliteal artery or below the ankle joint space
-Inflow lesion or occlusion in the ipsilateral Iliac, SFA, popliteal arteries with length >=15 cm
-Significant (>=50% DS) inflow lesion or occlusion in the ipsilateral Iliac, SFA and popliteal arteries left untreated
-Previously implanted stent in the TL(s)
-Aneurysm in the target vessel
-Acute thrombus in the target limb
-Failure to obtain a <30% residual stenosis in pre-existing, hemodynamically significant (>=50% DS and <15 cm length) inflow lesions in the ipsilateral iliac, SFA and popliteal artery. No Drug Eluting Stents (DES) and / or DEB allowed for the treatment of inflow lesions
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 |
|---|---|
| Other | http://clinicaltrials.gov/ct2/results?term=IN.PACT+DEEP |
| CCMO | NL36046.100.11 |