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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Diseases
• Intervention / Treatment: Device: balloon angioplasty; Device: drug eluting 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04289
    • Universität Leipzig - Herzzentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-Segment Binary Restenosis	12-months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean percent diameter stenosis (%DS) and minimal lumen diameter (MLD) measured by quantitative angiography post-procedure.	12 months
In-segment late loss measured by quantitative angiography.	12 months
In-stent late loss measured by quantitative angiography.	12 months
Patency defined as detectable flow measured by Duplex Ultrasound.	6 weeks, 6 and 12 months
Target Lesion Revascularization (TLR), and Target Vessel Revascularization (TVR).	6 weeks, 6 and 12 months;
Assessment for stent fractures by X-Ray.	12 months
Device Success defined as achievement of a final residual diameter stenosis of <30% (by QA), using the assigned device only.	post procedure
Lesion Success defined as achievement of <50% (by QA) residual stenosis using any percutaneous method.	post procedure
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.	post procedure
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.	post procedure
Serious Adverse Events	At procedure up to discharge, 6 weeks, 6 and 12 months
Rutherford classification	At screening, 6 weeks, 6 and 12 months
Ankle Brachial Index measured	At screening, 6 weeks, 6 and 12 months
Amputation	6 weeks, 6 and 12 months
Quality of Life assessment.	6 weeks, 6 and 12 months
Wound status of index limb (if applicable) due to CLI measured by digital photography, depth/length/width measurements, infection and wound closure status.	screening, 6 weeks, 6 and 12 months

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: Dierk Scheinert, MD, PhD, Universität Leipzig - Herzzentrum

Publications and helpful links

General Publications

• Katsanos K, Spiliopoulos S, Diamantopoulos A, Siablis D, Karnabatidis D, Scheinert D. Wound Healing Outcomes and Health-Related Quality-of-Life Changes in the ACHILLES Trial: 1-Year Results From a Prospective Randomized Controlled Trial of Infrapopliteal Balloon Angioplasty Versus Sirolimus-Eluting Stenting in Patients With Ischemic Peripheral Arterial Disease. JACC Cardiovasc Interv. 2016 Feb 8;9(3):259-267. doi: 10.1016/j.jcin.2015.10.038. Epub 2016 Jan 6.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 14, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Estimate): March 15, 2011
• Last Update Submitted That Met QC Criteria: March 14, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: EE06-02