Status:
COMPLETED
Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
Lead Sponsor:
Medtronic Endovascular
Conditions:
Critical Lower Limb Ischemia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal ...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- Age ≥18 years and ≤85 years
- Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
- Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
- 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
- General Angiographic Inclusion Criteria
- Reference vessel(s) diameter between 2 and 4 mm
- Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in one or more main afferent crural vessels including the tibioperoneal trunk
- At least one non occluded crural vessel with angiographically documented run-off to the foot either direct or through collaterals
- Angiographic Inclusion Criteria for Late Lumen Loss (LLL) assessment
- Angio-target lesion (TL) is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis (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)
- Angio-target lesion (TL) is the only lesion in that vessel (only one Angio-TL per patient is allowed)
Exclusion
- General Exclusion Criteria
- Patient unwilling or unlikely to comply with Follow-Up schedule
- Planned major index limb amputation
- General Angiographic Exclusion Criteria
- 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, Superficial Femoral Artery (SFA), popliteal arteries with length ≥15 cm
- Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral Iliac, Superficial Femoral Artery (SFA) and popliteal arteries left untreated
- Previously implanted stent in the target lesions(s)
- Aneurysm in the target vessel
- Acute thrombus in the target limb
- General Procedural Exclusion Criteria
- Failure to obtain a \<30% residual stenosis in pre-existing, hemodynamically significant (≥50% diameter stenosis (DS) and \<15 cm length) inflow lesions in the ipsilateral iliac, SFA and popliteal artery. No Drug Eluting Stents (DES) and / or Drug Eluting Balloon (DEB) allowed for the treatment of inflow lesions.
- Failure to cross the TL with a 0.014" guide wire
- Use of alternative therapy, e.g. atherectomy, cutting balloon, laser, radiation therapy, DES as part of the index procedure
- ANGIOGRAPHIC cohort General
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT00941733
Start Date
September 1 2009
End Date
November 30 2017
Last Update
February 28 2018
Active Locations (13)
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1
Medical University Graz
Graz, Austria
2
Imelda Hospital
Bonheiden, Belgium
3
AZ Sint-Blasius
Dendermonde, Belgium
4
ZOL St. Jan
Genk, Belgium