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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Medtronic Endovascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 19, 2014