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

NCT00640770 | Completed Phase 4 DMC

• 1 other identifier: EE06-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 a prospective, multicenter, randomized clinical study.

Conditions

Peripheral Arterial Diseases

Outcome Measures

Primary Outcomes (1)

• In-Segment Binary Restenosis

  12-months

Secondary Outcomes (16)

• 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;

Study Arms (2)

balloon angioplasty

ACTIVE COMPARATOR

balloon angioplasty

Device: balloon angioplasty

Drug eluting stent

EXPERIMENTAL

CYPHER SELECT+ Coronary or Infrapopliteal Stent

Device: drug eluting stent

Interventions

balloon angioplasty DEVICE

balloon angioplasty

balloon angioplasty

drug eluting stent DEVICE

Cypher Select+ Coronary or Infrapopliteal Stent

Drug eluting stent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Universität Leipzig - Herzzentrum

Leipzig, 04289, Germany

Location

Related Publications (1)

• 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.

  PMID: 26777329 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty, Balloon; Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Dierk Scheinert, MD, PhD

  Universität Leipzig - Herzzentrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 21, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 15, 2011

Record last verified: 2011-03

Locations

DE (1)