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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 358
- Locations
- 13
- Primary Endpoint
- Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Drug Eluting Balloon
Intervention: IN.PACT Amphirion™
Intervention: IN.PACT Amphirion (Device)
Standard PTA
Intervention: Standard PTA
Intervention: Standard PTA (Device)
Outcomes
Primary Outcomes
Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients
Time Frame: 12 months
Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).
Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)
Time Frame: 12 months or at Target Lesion Revascularization (TLR) time
The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up
Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)
Time Frame: 6 months
Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)
Secondary Outcomes
- Amputation Free Survival(12 months)
- Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)(12 months)
- Secondary Sustained Clinical Improvement(12 months)
- Device Success(Day 1)
- Procedural Success(Day 1)
- Rate of Wound Healing(12 months)
- Amputation Free Survival and Wound Healing(12 months)
- Primary Sustained Clinical Improvement(12 months)
- Quality of Life Assessment by EQ5D(12 months)
- MAE (Major Adverse Events)(12 months)
- Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)(12 months)
- Walking Capacity Assessment(12 months)
- Days of Hospitalization(12 months)
- Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)(12 months)
- Technical Success(Day 1)