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Peripheral Arterial DiseasesPhase 4ACHILLESNCT00640770

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

A Phase 4 study testing balloon angioplasty and drug eluting stent in people with Peripheral Arterial Diseases, run by Cordis US Corp. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Peripheral Arterial Diseases
What is being tested?
balloon angioplasty and drug eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteGermany
Study dates
Mar 2008to Jan 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universität Leipzig - Herzzentrum

    Leipzig, 04289

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
balloon angioplasty, drug eluting stent
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • balloon angioplastyDevice

    balloon angioplasty

  • drug eluting stentDevice

    Cypher Select+ Coronary or Infrapopliteal Stent

Study groups in NCT00640770
Study groupRoleWhat they receive
balloon angioplastyActive comparatorballoon angioplasty
Receives: Device: balloon angioplasty
Drug eluting stentExperimentalCYPHER SELECT+ Coronary or Infrapopliteal Stent
Receives: Device: drug eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-Segment Binary Restenosis

    Measured: 12-months

Secondary outcomes (16)

  1. Mean percent diameter stenosis (%DS) and minimal lumen diameter (MLD) measured by quantitative angiography post-procedure.

    Measured: 12 months

  2. In-segment late loss measured by quantitative angiography.

    Measured: 12 months

  3. In-stent late loss measured by quantitative angiography.

    Measured: 12 months

  4. Patency defined as detectable flow measured by Duplex Ultrasound.

    Measured: 6 weeks, 6 and 12 months

  5. Target Lesion Revascularization (TLR), and Target Vessel Revascularization (TVR).

    Measured: 6 weeks, 6 and 12 months;

  6. Assessment for stent fractures by X-Ray.

    Measured: 12 months

  7. Device Success defined as achievement of a final residual diameter stenosis of <30% (by QA), using the assigned device only.

    Measured: post procedure

  8. Lesion Success defined as achievement of <50% (by QA) residual stenosis using any percutaneous method.

    Measured: post procedure

  9. 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.

    Measured: post procedure

  10. 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.

    Measured: post procedure

  11. Serious Adverse Events

    Measured: At procedure up to discharge, 6 weeks, 6 and 12 months

  12. Rutherford classification

    Measured: At screening, 6 weeks, 6 and 12 months

  13. Ankle Brachial Index measured

    Measured: At screening, 6 weeks, 6 and 12 months

  14. Amputation

    Measured: 6 weeks, 6 and 12 months

  15. Quality of Life assessment.

    Measured: 6 weeks, 6 and 12 months

  16. Wound status of index limb (if applicable) due to CLI measured by digital photography, depth/length/width measurements, infection and wound closure status.

    Measured: screening, 6 weeks, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00640770
Sponsor's protocol ID
EE06-02
Acronym
ACHILLES
Status last verified
Mar 2011
First submitted
14 Mar 2008
Last updated
15 Mar 2011
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 26777329

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing balloon angioplasty and drug eluting stent in people with Peripheral Arterial Diseases, run by Cordis US Corp. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-Segment Binary Restenosis (time frame: 12-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00640770, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2011.

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