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

NCT ID: NCT00941733

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2017-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug Eluting Balloon

Intervention: IN.PACT Amphirion™

Group Type: EXPERIMENTAL

IN.PACT Amphirion

Intervention Type: DEVICE

Balloon Angioplasty

Standard PTA

Intervention: Standard PTA

Group Type: ACTIVE_COMPARATOR

Standard PTA

Intervention Type: DEVICE

Balloon Angioplasty

Interventions

IN.PACT Amphirion

Balloon Angioplasty

Intervention Type: DEVICE

Standard PTA

Balloon Angioplasty

Intervention Type: DEVICE

Eligibility Criteria

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

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dierk Scheinert, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Thomas Zeller, MD

Role: PRINCIPAL_INVESTIGATOR

University Heart Center Freiburg - Bad Krozingen

Iris Baumgartner, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

Medical University Graz

Graz, , Austria

Imelda Hospital

Bonheiden, , Belgium

AZ Sint-Blasius

Dendermonde, , Belgium

ZOL St. Jan

Genk, , Belgium

Ghent University Hospital

Ghent, , Belgium

Herz-Zentrum Bad Krozingen

Bad Krozingen, , Germany

Medical Care Center

Hamburg, , Germany

University Hospital Heidelberg

Heidelberg, , Germany

Park-Krankenhaus Leipzig

Leipzig, , Germany

Villa Maria Eleonora Hospital

Palermo, , Italy

St. Antonius Hospital

Nieuwegein, , Netherlands

University of Bern

Bern, , Switzerland

Luzerner Kantonsspital

Lucerne, , Switzerland

Countries

Austria; Belgium; Germany; Italy; Netherlands; Switzerland

References

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.

Reference Type: DERIVED

PMID: 32081236 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25301459 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24552184 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/24552184

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

Other Identifiers

P998

Identifier Type: -

Identifier Source: org_study_id