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: October 24, 2014
Last verified: October 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 (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.


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

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 (Percutaneous Transluminal Angioplasty) for the Treatment of Below the Knee Critical Limb Ischemia

Resource links provided by NLM:


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 Target Lesion Revascularization (TLR) time ] [ Designated as safety issue: No ]
    The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up

  • Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).

  • Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • Amputation Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of participants with a 1 year amputation free survival.

  • Rate of Wound Healing [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of participants with completed wound healing, wound healing as defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.

  • Amputation Free Survival and Wound Healing [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of participants with a 1 year amputation free survival and wound healing. Wound healing is defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at a specified time point.

  • Amputation Free Survival and Resolved Critical Limb Ischemia (CLI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of participants with an amputation free survival and resolved Critical Limb Ischemia (CLI) at 1 year.

  • Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Percentage of participants that experienced death, amputation and clinically driven Target Lesion Revascularization (TLR) at 1 year.

  • Primary Sustained Clinical Improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of participants that experienced primary sustained clinical improvement at 1 year, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.

  • Secondary Sustained Clinical Improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects at 1 year.

  • Quality of Life Assessment by EQ5D [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Quality of life assessment by EQ5D at 1 year compared to baseline. EQ-5D is a standardised measure of health status and economic appraisal. The EQ-5D-3L essentially consists of 2 parts:the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

    EQ-5D health states can be converted into a single summary index where 0.0='worst possible outcome' and 1.0='best possible outcome'.


  • Walking Capacity Assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Walking Impairment assessment by WIQ at 1 year compared to baseline. The Walking Impairment Questionnaire (WIQ) is a questionnaire for evaluating walking impairment in patients with peripheral arterial disease (PAD). This can be used to identify patients with significant impairment and to monitor effectiveness of therapeutic interventions. The questionnaire was self-administered by the patients and contains three domains measuring three important factors of walking impairment in patients with intermittent claudication: (1) difficulty walking a distance during the past month, (2) difficulty walking at a certain speed during the past month, (3) symptoms associated with walking impairment. For each separate domain, a subscore was calculated. The total WIQ score was defined as the mean of the three subscores.

    A WIQ score of 42.5 or less identified low performers; while a score of 75.5 or more identified high performers. The WIQ score range is 0 (minimum) - 100 (maximum).


  • MAE (Major Adverse Events) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Percentage of participants with a MAE (Major Adverse Events) at 1 year. Major Adverse Events, defined as Death of any Cause, Major Amputation of target limb, Minor Amputation of target limb

  • Device Success [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percentage of device success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities

  • Technical Success [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percentage of technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography

  • Procedural Success [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Percentage of patients with a procedural success defined as combination of technical success, device success and absence of procedural complications

  • Days of Hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Days of hospitalization at 1 year

  • Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of participants with an improvement in percent diameter stenosis (%DS) of the target leasion (TL) assessed by Quantitative Vascular Angiography (QVA)


Enrollment: 358
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
Intervention: IN.PACT Amphirion™
Device: IN.PACT Amphirion
Balloon Angioplasty
Other Name: IN.PACT Amphirion
Active Comparator: Standard PTA
Intervention: Standard PTA
Device: Standard PTA
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 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

  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
Austria
Medical University Graz
Graz, Austria
Belgium
Imelda Hospital
Bonheiden, Belgium
AZ Sint-Blasius
Dendermonde, Belgium
ZOL St. Jan
Genk, Belgium
Ghent University Hospital
Gent, Belgium
Germany
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Medical Care Center
Hamburg, Germany
University Hospital Heidelberg
Heidelberg, Germany
Park-Krankenhaus Leipzig
Leipzig, Germany, 04289
Italy
Villa Maria Eleonora Hospital
Palermo, Italy
Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Switzerland
University of Bern
Bern, Switzerland, 3010
Luzerner Kantonsspital
Luzern, Switzerland
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
Results First Received: August 29, 2014
Last Updated: October 24, 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
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 October 30, 2014