Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia

NCT00941733 | Completed Results DMC

• 1 other identifier: P998
• Study Type: interventional
• Target: 358
• Locations: 6 countries
• Sites: 13

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.

Conditions

Critical Lower Limb Ischemia

Keywords

BTK; CLI; PTA

Outcome Measures

Primary Outcomes (3)

• Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)

  The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up

  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

  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).

  12 months

• Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)

  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)

  6 months

Secondary Outcomes (15)

• Amputation Free Survival

  12 months

• Rate of Wound Healing

  12 months

• Amputation Free Survival and Wound Healing

  12 months

• Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)

  12 months

• Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)

  12 months

Study Arms (2)

Drug Eluting Balloon

EXPERIMENTAL

Intervention: IN.PACT Amphirion™

Device: IN.PACT Amphirion

Standard PTA

ACTIVE COMPARATOR

Intervention: Standard PTA

Device: Standard PTA

Interventions

IN.PACT Amphirion DEVICE

Balloon Angioplasty

Drug Eluting Balloon

Standard PTA DEVICE

Balloon Angioplasty

Standard PTA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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)

You may not qualify if:

• Patient unwilling or unlikely to comply with Follow-Up schedule
• 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, 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
• 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
• \- Glomerular Filtration Rate (GFR) \<30 ml/min except for patients with renal end stage disease on chronic haemodialysis

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (13)

Medical University Graz

Graz, Austria

Location

Imelda Hospital

Bonheiden, Belgium

Location

AZ Sint-Blasius

Dendermonde, Belgium

Location

ZOL St. Jan

Genk, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

Herz-Zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Medical Care Center

Hamburg, Germany

Location

University Hospital Heidelberg

Heidelberg, Germany

Location

Park-Krankenhaus Leipzig

Leipzig, 04289, Germany

Location

Villa Maria Eleonora Hospital

Palermo, Italy

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

University of Bern

Bern, 3010, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 32081236 DERIVED

• 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.

  PMID: 25301459 DERIVED

• 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.

  PMID: 24552184 DERIVED

Related Links

• Zeller et al. Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapoplliteal Arterial Revascularization in CLI - 12-Month Results from the IN.PACT DEEP Randomized trial.Journal of the American College of Cardiology 2014; 64; 15

Results Point of Contact

• Title: Clinical Research Director
• Organization: Medtronic - CardioVascular

kristel.wittebols@medtronic.com

+31433566580

Study Officials

• Dierk Scheinert, MD

  Heart Center Leipzig - University Hospital

  PRINCIPAL INVESTIGATOR

• Thomas Zeller, MD

  University Heart Center Freiburg - Bad Krozingen

  PRINCIPAL INVESTIGATOR

• Iris Baumgartner, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 20, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: November 30, 2017
• Last Updated: February 28, 2018
• Results First Posted: October 27, 2014

Record last verified: 2018-01

Locations

DE (4); CH (2); IT (1); BE (4); AU (1); NL (1)