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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00941733
First received: July 16, 2009
Last updated: February 3, 2014
Last verified: January 2014
  Purpose

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 PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.


Condition Intervention
Chronic Critical Limb Ischemia
Device: IN.PACT Amphirion
Device: Standard PTA balloon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Late lumen loss (LLL) of the target lesion by quantitative vascular angiography (QVA) [ Time Frame: 12 months or at TLR time ] [ Designated as safety issue: No ]
  • Clinically driven TLR of the target lesion in the amputation free surviving patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Composite of all cause death, major amputation and clinically driven TLR [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Amputation free survival [ Time Frame: 30 days, 3 and 6 months, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: No ]
  • Rate of wound healing [ Time Frame: 30 days, 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
  • Amputation free survival and wound healing [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
  • Amputation free survival and resolved CLI [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
  • Death, amputation and clinically driven TLR [ Time Frame: 30 days, 6 months, 1 and 2 years ] [ Designated as safety issue: Yes ]
  • Primary sustained clinical improvement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Secondary sustained clinical improvement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of life assessment by EQ5D vs. baseline [ Time Frame: 6 months, 1, and 2 years ] [ Designated as safety issue: No ]
  • Walking capacity assessment vs. baseline [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
  • MAE (Major Adverse Events) [ Time Frame: 30 days, 6 months, 1, 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]
  • Device Success [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Technical Success [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Procedural Success [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Days of hospitalization [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Improvement % diameter stenosis (%DS) of the TL assessed by Quantitative Vascular Angiography (QVA) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 357
Study Start Date: September 2009
Estimated Study Completion Date: August 2017
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug Eluting Balloon Device: IN.PACT Amphirion
Balloon Angioplasty
Other Name: IN.PACT Amphirion
Active Comparator: standard PTA Device: Standard PTA balloon
Balloon Angioplasty

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 EC 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% 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-TL is one identifiable single solitary or series of multiple adjacent lesions with a 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-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 FU 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, SFA, popliteal arteries with length ≥15 cm
  • Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral Iliac, SFA and popliteal arteries left untreated
  • Previously implanted stent in the TL(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% DS and <15 cm length) inflow lesions in the ipsilateral iliac, SFA and popliteal artery. No Drug Eluting Stents (DES) and / or 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:

- GFR <30 ml/min except for patients with renal end stage disease on chronic haemodialysis

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941733

Locations
Germany
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Park-Krankenhaus Leipzig
Leipzig, Germany, 04289
Switzerland
University of Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Dierk Scheinert, MD Herzzentrum Leipzig
Principal Investigator: Thomas Zeller, MD Heart Center Bad Krozingen
Principal Investigator: Iris Baumgartner, MD University Hospital Inselspital, Berne
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00941733     History of Changes
Other Study ID Numbers: P998
Study First Received: July 16, 2009
Last Updated: February 3, 2014
Health Authority: Italy: Ethics Committee
Germany: Ethics Commission
Germany: German Institute of Medical Documentation and Information
Belgium: Institutional Review Board
Austria: Ethikkommission
Switzerland: Ethikkommission
The Netherlands: Independent Ethics Committee

Keywords provided by Medtronic Endovascular:
BTK
CLI
PTA

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014