PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

NCT00471289 | Unknown Phase 2

• 1 other identifier: PADI/200601
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA).

Conditions

Peripheral Vascular Disease

Keywords

Critical Limb Ischemia; Stents; Drug Eluting Stents; Peripheral arterial disease; PAD; Paclitaxel; TAXUS; Infrapopliteal; Infragenicular; Interventional Radiology; CLI; DES

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim.

  6 months

Secondary Outcomes (13)

• Primary patency of the treated sites at 3, 6 and 12 months after intervention assessed by duplex sonography (binary patency, <50% stenosis defined as PSV ratio <2.0)

  3, 6, 12 months

• Clinical evaluation of the treated ischemic leg at 3, 6 and 12 months.

  3, 6, 12 months

• Major amputation (at or above the ankle) of the trial leg at 3, 6 and 12 months

  3, 6, 12 months

• Minor amputation (below the ankle excluding the toes) of the trial leg at 3, 6 and 12 months.

  3, 6, 12 months

• Infrapopliteal surgical bypass of the trial leg at 3, 6 and 12 months.

  3, 6, 12 months

Study Arms (2)

1

EXPERIMENTAL

PTA with primary placement of Drug (paclitaxel) Eluting Stent

Device: PTA with placement of paclitaxel-eluting stent

2

ACTIVE COMPARATOR

PTA

Device: PTA

Interventions

PTA with placement of paclitaxel-eluting stent DEVICE

PTA with placement of paclitaxel-eluting stent

1

PTA DEVICE

PTA

2

Eligibility Criteria

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

You may qualify if:

• Written informed consent
• Age \> 18 years
• If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study
• Patient is willing and able to comply with the specified follow-up evaluation
• Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss)
• Stenotic (\>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length ≤ 60 mm
• Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm
• Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session
• At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment

You may not qualify if:

• Acute limb ischaemia
• Subacute limb ischaemia which requires thrombolysis as first treatment modality
• Active bleeding or bleeding diathesis
• Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair
• Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment
• Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side
• Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure
• Previous implanted stent at the index site
• Life expectancy of less than 6 months or other factors making clinical follow-up difficult
• Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel
• Known allergy to contrast media
• Known heparin induced thrombocytopenia (HIT type 2)
• Patient unable or unwilling to tolerate anticoagulant, anti-platelet therapy or contrast media
• Creatinine clearance \< 20 ml/min (as derived from Cockcroft-Gault or MDRD formula)unless patient is on hemodialysis
• Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side

Sponsors & Collaborators

• Netherlands Society for Interventional Radiology: lead

Study Sites (3)

HagaZiekenhuis, location Leyweg

The Hague, South Holland, 2545CH, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Location

University Medical Center Utrecht (UMCU)

Utrecht, 3584 CX, Netherlands

Location

Related Publications (19)

• Management of peripheral arterial disease (PAD). TransAtlantic Inter-Society Consensus (TASC). Section D: chronic critical limb ischaemia. Eur J Vasc Endovasc Surg. 2000 Jun;19 Suppl A:S144-243. No abstract available.

  PMID: 10957907 BACKGROUND

• Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5.

  PMID: 16325694 BACKGROUND

• Jensen SA, Vatten LJ, Myhre HO. The prevalence of chronic critical lower limb ischaemia in a population of 20,000 subjects 40-69 years of age. Eur J Vasc Endovasc Surg. 2006 Jul;32(1):60-5. doi: 10.1016/j.ejvs.2005.12.022. Epub 2006 Mar 2.

  PMID: 16513377 BACKGROUND

• Black JH 3rd, LaMuraglia GM, Kwolek CJ, Brewster DC, Watkins MT, Cambria RP. Contemporary results of angioplasty-based infrainguinal percutaneous interventions. J Vasc Surg. 2005 Nov;42(5):932-9. doi: 10.1016/j.jvs.2005.06.024.

  PMID: 16275450 BACKGROUND

• Sigala F, Menenakos Ch, Sigalas P, Baunach Ch, Langer S, Papalambros E, Hepp W. Transluminal angioplasty of isolated crural arterial lesions in diabetics with critical limb ischemia. Vasa. 2005 Aug;34(3):186-91. doi: 10.1024/0301-1526.34.3.186.

  PMID: 16184838 BACKGROUND

• Hynes N, Mahendran B, Manning B, Andrews E, Courtney D, Sultan S. The influence of subintimal angioplasty on level of amputation and limb salvage rates in lower limb critical ischaemia: a 15-year experience. Eur J Vasc Endovasc Surg. 2005 Sep;30(3):291-9. doi: 10.1016/j.ejvs.2005.04.020.

  PMID: 15939635 BACKGROUND

• Eskelinen E, Alback A, Roth WD, Lappalainen K, Keto P, Railo M, Eskelinen A, Lepantalo M. Infra-inguinal percutaneous transluminal angioplasty for limb salvage: a retrospective analysis in a single center. Acta Radiol. 2005 Apr;46(2):155-62. doi: 10.1080/02841850510022705.

  PMID: 15902890 BACKGROUND

• Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg. 2005 Mar;41(3):423-35; discussion 435. doi: 10.1016/j.jvs.2004.11.041.

  PMID: 15838475 BACKGROUND

• Atar E, Siegel Y, Avrahami R, Bartal G, Bachar GN, Belenky A. Balloon angioplasty of popliteal and crural arteries in elderly with critical chronic limb ischemia. Eur J Radiol. 2005 Feb;53(2):287-92. doi: 10.1016/j.ejrad.2004.02.016.

  PMID: 15664294 BACKGROUND

• Tsetis D, Belli AM. The role of infrapopliteal angioplasty. Br J Radiol. 2004 Dec;77(924):1007-15. doi: 10.1259/bjr/97382129.

  PMID: 15569642 BACKGROUND

• Matsagas MI, Rivera MA, Tran T, Mitchell A, Robless P, Davies AH, Geroulakos G. Clinical outcome following infra-inguinal percutaneous transluminal angioplasty for critical limb ischemia. Cardiovasc Intervent Radiol. 2003 May-Jun;26(3):251-5. doi: 10.1007/s00270-003-0007-z.

  PMID: 14562973 BACKGROUND

• Molloy KJ, Nasim A, London NJ, Naylor AR, Bell PR, Fishwick G, Bolia A, Thompson MM. Percutaneous transluminal angioplasty in the treatment of critical limb ischemia. J Endovasc Ther. 2003 Apr;10(2):298-303. doi: 10.1177/152660280301000220.

  PMID: 12877613 BACKGROUND

• Haider SN, Kavanagh EG, Forlee M, Colgan MP, Madhavan P, Moore DJ, Shanik GD. Two-year outcome with preferential use of infrainguinal angioplasty for critical ischemia. J Vasc Surg. 2006 Mar;43(3):504-512. doi: 10.1016/j.jvs.2005.11.016.

  PMID: 16520164 BACKGROUND

• Wiskirchen J, Schober W, Schart N, Kehlbach R, Wersebe A, Tepe G, Claussen CD, Duda SH. The effects of paclitaxel on the three phases of restenosis: smooth muscle cell proliferation, migration, and matrix formation: an in vitro study. Invest Radiol. 2004 Sep;39(9):565-71. doi: 10.1097/01.rli.0000133815.22434.55.

  PMID: 15308939 BACKGROUND

• Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. doi: 10.1056/NEJMra051091. No abstract available.

  PMID: 16452560 BACKGROUND

• Aoki J, Colombo A, Dudek D, Banning AP, Drzewiecki J, Zmudka K, Schiele F, Russell ME, Koglin J, Serruys PW; TAXUS II Study Group. Peristent remodeling and neointimal suppression 2 years after polymer-based, paclitaxel-eluting stent implantation: insights from serial intravascular ultrasound analysis in the TAXUS II study. Circulation. 2005 Dec 20;112(25):3876-83. doi: 10.1161/CIRCULATIONAHA.105.558601. Epub 2005 Dec 12.

  PMID: 16344384 BACKGROUND

• Spreen MI, Martens JM, Knippenberg B, van Dijk LC, de Vries JPM, Vos JA, de Borst GJ, Vonken EPA, Bijlstra OD, Wever JJ, Statius van Eps RG, Mali WPTM, van Overhagen H. Long-Term Follow-up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia. J Am Heart Assoc. 2017 Apr 14;6(4):e004877. doi: 10.1161/JAHA.116.004877.

  PMID: 28411244 DERIVED

• Spreen MI, Martens JM, Hansen BE, Knippenberg B, Verhey E, van Dijk LC, de Vries JP, Vos JA, de Borst GJ, Vonken EJ, Wever JJ, Statius van Eps RG, Mali WP, van Overhagen H. Percutaneous Transluminal Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI) Trial. Circ Cardiovasc Interv. 2016 Feb;9(2):e002376. doi: 10.1161/CIRCINTERVENTIONS.114.002376.

  PMID: 26861113 DERIVED

• Martens JM, Knippenberg B, Vos JA, de Vries JP, Hansen BE, van Overhagen H; PADI Trial Group. Update on PADI trial: percutaneous transluminal angioplasty and drug-eluting stents for infrapopliteal lesions in critical limb ischemia. J Vasc Surg. 2009 Sep;50(3):687-9. doi: 10.1016/j.jvs.2009.04.073.

  PMID: 19700099 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Hans Van Overhagen, MD PhD

  HagaZiekenhuis Dept. of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiologist Haga Teaching Hospital The Hague

Study Record Dates

• First Submitted: May 7, 2007
• First Posted: May 9, 2007
• Study Start: August 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2023
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

NL (3)