Clinical trial NCT00941733: Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Lower Limb Ischemia
Keywords: BTK
CLI
PTA
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2009-07-20
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)
timeFrame: 12 months or at Target Lesion Revascularization (TLR) time
measure: Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients
timeFrame: 12 months
measure: Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)
timeFrame: 6 months
Secondary outcomes:
measure: Amputation Free Survival
timeFrame: 12 months
measure: Rate of Wound Healing
timeFrame: 12 months
measure: Amputation Free Survival and Wound Healing
timeFrame: 12 months
measure: Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)
timeFrame: 12 months
measure: Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)
timeFrame: 12 months
measure: Primary Sustained Clinical Improvement
timeFrame: 12 months
measure: Secondary Sustained Clinical Improvement
timeFrame: 12 months
measure: Quality of Life Assessment by EQ5D
timeFrame: 12 months
measure: Walking Capacity Assessment
timeFrame: 12 months
measure: MAE (Major Adverse Events)
timeFrame: 12 months
measure: Device Success
timeFrame: Day 1
measure: Technical Success
timeFrame: Day 1
measure: Procedural Success
timeFrame: Day 1
measure: Days of Hospitalization
timeFrame: 12 months
measure: Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)
timeFrame: 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Genk
country: Belgium
facility: ZOL St. Jan
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
city: Hamburg
country: Germany
facility: Medical Care Center
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Leipzig
country: Germany
facility: Park-Krankenhaus Leipzig
city: Palermo
country: Italy
facility: Villa Maria Eleonora Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Bern
country: Switzerland
facility: University of Bern
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Dierk Scheinert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heart Center Freiburg - Bad Krozingen
name: Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Insel Gruppe AG, University Hospital Bern
name: Iris Baumgartner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeller T, Micari A, Scheinert D, Baumgartner I, Bosiers M, Vermassen FEG, Banyai M, Shishehbor MH, Wang H, Brodmann M; IN.PACT DEEP Trial Investigators. The IN.PACT DEEP Clinical Drug-Coated Balloon Trial: 5-Year Outcomes. JACC Cardiovasc Interv. 2020 Feb 24;13(4):431-443. doi: 10.1016/j.jcin.2019.10.059.
citation: Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M, Snead DB, Kent KC, Rocha-Singh KJ; IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014 Oct 14;64(15):1568-76. doi: 10.1016/j.jacc.2014.06.1198.
citation: Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M; IN.PACT DEEP Trial Investigators. IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial. Trials. 2014 Feb 19;15:63. doi: 10.1186/1745-6215-15-63.