This trial is active, not recruiting.

Condition critical lower limb ischemia
Treatments in.pact amphirion, standard pta
Sponsor Medtronic Endovascular
Start date September 2009
End date August 2013
Trial size 358 participants
Trial identifier NCT00941733, P998


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 vessels. Patients will undergo a percutaneous transluminal endovascular procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Intervention: IN.PACT Amphirion™
in.pact amphirion
Balloon Angioplasty
(Active Comparator)
Intervention: Standard PTA
standard pta
Balloon Angioplasty

Primary Outcomes

Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)
time frame: 12 months or at Target Lesion Revascularization (TLR) time
Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients
time frame: 12 months
Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)
time frame: 6 months

Secondary Outcomes

Amputation Free Survival
time frame: 12 months
Rate of Wound Healing
time frame: 12 months
Amputation Free Survival and Wound Healing
time frame: 12 months
Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)
time frame: 12 months
Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)
time frame: 12 months
Primary Sustained Clinical Improvement
time frame: 12 months
Secondary Sustained Clinical Improvement
time frame: 12 months
Quality of Life Assessment by EQ5D
time frame: 12 months
Walking Capacity Assessment
time frame: 12 months
MAE (Major Adverse Events)
time frame: 12 months
Device Success
time frame: Day 1
Technical Success
time frame: Day 1
Procedural Success
time frame: Day 1
Days of Hospitalization
time frame: 12 months
Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: 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 Criteria: 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 Exclusion Criteria: - Glomerular Filtration Rate (GFR) <30 ml/min except for patients with renal end stage disease on chronic haemodialysis

Additional Information

Official title Randomized Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA (Percutaneous Transluminal Angioplasty) for the Treatment of Below the Knee Critical Limb Ischemia
Principal investigator Dierk Scheinert, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.