Peripheral Arterial Diseases Clinical Trial
— ACHILLESOfficial 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.
Status | Completed |
Enrollment | 200 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Universität Leipzig - Herzzentrum | Leipzig |
Lead Sponsor | Collaborator |
---|---|
Cordis Corporation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-Segment Binary Restenosis | 12-months | No | |
Secondary | Mean percent diameter stenosis (%DS) and minimal lumen diameter (MLD) measured by quantitative angiography post-procedure. | 12 months | No | |
Secondary | In-segment late loss measured by quantitative angiography. | 12 months | No | |
Secondary | In-stent late loss measured by quantitative angiography. | 12 months | No | |
Secondary | Patency defined as detectable flow measured by Duplex Ultrasound. | 6 weeks, 6 and 12 months | No | |
Secondary | Target Lesion Revascularization (TLR), and Target Vessel Revascularization (TVR). | 6 weeks, 6 and 12 months; | Yes | |
Secondary | Assessment for stent fractures by X-Ray. | 12 months | No | |
Secondary | Device Success defined as achievement of a final residual diameter stenosis of <30% (by QA), using the assigned device only. | post procedure | No | |
Secondary | Lesion Success defined as achievement of <50% (by QA) residual stenosis using any percutaneous method. | post procedure | No | |
Secondary | 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 | No | |
Secondary | 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 | Yes | |
Secondary | Serious Adverse Events | At procedure up to discharge, 6 weeks, 6 and 12 months | Yes | |
Secondary | Rutherford classification | At screening, 6 weeks, 6 and 12 months | No | |
Secondary | Ankle Brachial Index measured | At screening, 6 weeks, 6 and 12 months | No | |
Secondary | Amputation | 6 weeks, 6 and 12 months | Yes | |
Secondary | Quality of Life assessment. | 6 weeks, 6 and 12 months | No | |
Secondary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02041169 -
Lower Extremity Peripheral Arterial Disease and Exercise Ischemia
|
N/A | |
Completed |
NCT01436435 -
The Jetstream (JET) Post-market Registry
|
Phase 4 | |
Completed |
NCT01983449 -
Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease
|
Phase 4 | |
Completed |
NCT03469349 -
Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
|
Phase 3 | |
Recruiting |
NCT05192707 -
Transcutaneous Oxygen Pressure (TcPO2) Determination.
|
||
Withdrawn |
NCT02531139 -
The Effect of Blood Pressure on Cerebral Perfusion During Vascular Surgery
|
N/A | |
Completed |
NCT00652418 -
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography
|
Phase 2 | |
Completed |
NCT02920125 -
Study the Result of Ayurvedic SUVED & Reimmugen (Colostrum) Treatment on Vascular Disease, CAD, CVA, DVT.
|
Phase 3 | |
Completed |
NCT02273232 -
Effects of Remote Ischemic Preconditioning on Moderate PVD Patients A Pilot Randomized Control Trial
|
Phase 1 | |
Completed |
NCT01952756 -
Effect of Cilostazol Endothelial Progenitor Cells and Collateral Formation in Peripheral Occlusive Artery Disease (PAOD)
|
Phase 4 | |
Completed |
NCT01419418 -
Patients' Perspectives of Factors That Support the Management of Peripheral Arterial Disease for Improved Outcomes
|
N/A | |
Completed |
NCT02066740 -
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
|
N/A | |
Completed |
NCT01336101 -
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent
|
N/A |