Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease (ACHILLES)

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00640770
First received: March 14, 2008
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

The primary objective of this study is to compare the performance of the CYPHER SELECTTM + Sirolimus-eluting Balloon-expandable Coronary and Infrapopliteal Stent over balloon angioplasty in de novo and restenotic native below the knee tibioperoneal, anterior and/or posterior tibial and/or peroneal arterial lesions in a prospective, multicenter, randomized clinical study.


Condition Intervention Phase
Peripheral Arterial Diseases
Device: balloon angioplasty
Device: drug eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter Comparison of Balloon Angioplasty and the Cypher Selecttm + Coronary and Infrapopliteal Stent in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • In-Segment Binary Restenosis [ Time Frame: 12-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean percent diameter stenosis (%DS) and minimal lumen diameter (MLD) measured by quantitative angiography post-procedure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • In-segment late loss measured by quantitative angiography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • In-stent late loss measured by quantitative angiography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patency defined as detectable flow measured by Duplex Ultrasound. [ Time Frame: 6 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR), and Target Vessel Revascularization (TVR). [ Time Frame: 6 weeks, 6 and 12 months; ] [ Designated as safety issue: Yes ]
  • Assessment for stent fractures by X-Ray. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Device Success defined as achievement of a final residual diameter stenosis of <30% (by QA), using the assigned device only. [ Time Frame: post procedure ] [ Designated as safety issue: No ]
  • Lesion Success defined as achievement of <50% (by QA) residual stenosis using any percutaneous method. [ Time Frame: post procedure ] [ Designated as safety issue: No ]
  • Procedural Success defined as achievement of final diameter stenosis of <50% (by QA) using any percutaneous method, without the occurrence of an SAE up to catheter sheath removal or subject leaving the cath lab, whichever is earlier. [ Time Frame: post procedure ] [ Designated as safety issue: No ]
  • Procedural Complications defined as any adverse event from the time of arterial punction up to the moment of catheter sheath removal or subject leaving the cath lab, whichever is earlier. [ Time Frame: post procedure ] [ Designated as safety issue: Yes ]
  • Serious Adverse Events [ Time Frame: At procedure up to discharge, 6 weeks, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Rutherford classification [ Time Frame: At screening, 6 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
  • Ankle Brachial Index measured [ Time Frame: At screening, 6 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
  • Amputation [ Time Frame: 6 weeks, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Quality of Life assessment. [ Time Frame: 6 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
  • Wound status of index limb (if applicable) due to CLI measured by digital photography, depth/length/width measurements, infection and wound closure status. [ Time Frame: screening, 6 weeks, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: March 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: balloon angioplasty
balloon angioplasty
Device: balloon angioplasty
balloon angioplasty
Experimental: Drug eluting stent
CYPHER SELECT+ Coronary or Infrapopliteal Stent
Device: drug eluting stent
Cypher Select+ Coronary or Infrapopliteal Stent

Detailed Description:

This is a multicenter, prospective, randomized study to be conducted in 18 centers in Europe. A total of 200 subjects will be entered into the study and will be randomized on a 1:1 basis to either balloon angioplasty or the CYPHER SELECTTM + Coronary and Infrapopliteal Stent for infrapopliteal use in subjects with symptomatic peripheral artery disease (Rutherford 3, 4, or 5).

All subjects will undergo a repeat angiography at 12 months to assess the primary endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 6 weeks, 6 and 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be >= 18 and <= 85 years old;
  • Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation;
  • Clinical diagnosis of symptomatic critical limb ischemia as defined by Rutherford 3, 4, or 5;
  • Single treatment of de novo or restenotic (after PTA only) lesion(s) in the tibioperoneal trunk, anterior and/or posterior tibial and/or peroneal artery;
  • A maximum of 2 vessels in 1 limb may be treated in the study, each vessel for only 1 target lesion, resulting in at single risk target lesion(s); In case 1 target lesion is located in the Tibioperoneal trunk, the 2nd target lesion (if applicable) can only be located in the anterior tibial artery; Additional non-target lesion(s) in remaining non-target vessel(s) can be treated at the physician's discretion by means of balloon dilation (± bail-out stenting);
  • The sum of the total length of both target lesions can be maximum 120 mm;
  • In total a maximum of 4 stents may be implanted to fully cover the maximum of 2 target lesions per subject;
  • Target vessel is >= 2.5 and <= 3.5 mm in diameter (visual estimate);
  • Target lesion stenosis is >70% diameter stenosis (visual estimate);
  • Guidewire must be across the first (if applicable) target lesion and located intraluminally within the distal vessel before study randomization;
  • Willing to comply with the specified follow-up evaluation;
  • Written informed consent prior to any study procedures.

Exclusion Criteria:

  • Significant (>50%) stenoses distal to the target lesion that might require revascularization, or impede runoff;
  • Angiographic evidence of thrombus within target vessel;
  • Thrombolysis within 72 hours prior to the index procedure;
  • Lesions not suitable for stenting;
  • Lesions (defined as stenosis > 75%) in the common or external iliac, common or superficial femoral and popliteal artery. However, intervention in TASC A and B lesions (max. 15cm) to restore adequate blood flow, in the same index procedure is allowed. This intervention must be prior to the treatment of the study lesion(s) and successful;
  • Lesions located at the bifurcation requiring treatment of both branches (1 in main branch and 1 in side branch);
  • Required stent placement across or within 1 cm of the knee joint; in an artery subject to external compression, or in an artery directly subject to movement of the ankle or knee joint;
  • Prior stent(s) within the target vessel(s);
  • Aneurysm in the SFA or popliteal artery;
  • Requiring popliteal arterial access;
  • Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;
  • Recent MI or stroke < 30 days prior to the index procedure;
  • Coronary intervention < 30 days prior to the index procedure;
  • Life expectancy less than 12 months;
  • Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb;
  • Impaired renal function (creatinine > 2.5 mg/dl);
  • Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (PlavixÒ) and ticlopidine (Ticlidâ), heparin, stainless steel or contrast agent;
  • The subject is currently taking Coumarin / Warfarin which, in the opinion of the investigator, interferes with the subject's participation in the study;
  • Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study;
  • The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00640770

Locations
Germany
Universität Leipzig - Herzzentrum
Leipzig, Germany, 04289
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Dierk Scheinert, MD, PhD Universität Leipzig - Herzzentrum
  More Information

No publications provided

Responsible Party: Hans-Peter Stoll - MD, PhD - Worldwide VP Clinical Research & Operations, Cordis
ClinicalTrials.gov Identifier: NCT00640770     History of Changes
Other Study ID Numbers: EE06-02
Study First Received: March 14, 2008
Last Updated: March 14, 2011
Health Authority: Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014