Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia

NCT02498080 | Unknown

• 1 other identifier: Pmp01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients suffering peripheral arterial occlusive disease (PAOD) provides good results in terms of limb salvage. During the last decade, drug eluting balloons (DEB) were found to be an effective tool for the treatment of atherosclerotic disease in several arterial districts. Aim of this study is to compare results of DEB PTA versus standard PTA of infra-popliteal district in patients with CLI, from a single-centre prospective randomized trial.

Conditions

Critical Limb Ischemia

Keywords

Drug eluting balloons; Critical limb ischemia; Infra-popliteal arteries; Percutaneous transluminal angioplasty

Outcome Measures

Primary Outcomes (1)

• binary restenosis rate

  binary restenosis rate has been defined as lumen loss \>50% at DSA

  12-months

Secondary Outcomes (4)

• clinically driven target lesion revascularization (CD-TLR) rate

  12-months

• major amputations rate

  12-months

• wound healing rate

  12-months

• target vessel occlusion rate

  12-months

Study Arms (2)

DEB PTA

EXPERIMENTAL

Devices: paclitaxel drug eluting balloon PTA

Procedure: DEB PTA

standard PTA

ACTIVE COMPARATOR

devices: standard balloon PTA

Procedure: Standard PTA

Interventions

DEB PTA PROCEDURE

paclitaxel drug eluting balloon PTA

DEB PTA

Standard PTA PROCEDURE

Standard PTA

standard PTA

Eligibility Criteria

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

You may qualify if:

• patients with CLI (Rutherford classes 4, 5, 6);
• stenosis and/or complete occlusion of P3 popliteal artery segment;
• stenosis and/or complete occlusion of at least 1 leg vessel \>40 mm in length;
• life-expectancy \>12 months;
• possibility to perform angiogram at 12-months follow-up.

You may not qualify if:

• life-expectancy \<12 months;
• iodinated contrast media or paclitaxel allergy;
• impossibility to undergo dual antiplatelet therapy.

Sponsors & Collaborators

• Neuromed IRCCS: lead

Related Publications (4)

• Forbes JF, Adam DJ, Bell J, Fowkes FG, Gillespie I, Raab GM, Ruckley CV, Bradbury AW; BASIL trial Participants. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis. J Vasc Surg. 2010 May;51(5 Suppl):43S-51S. doi: 10.1016/j.jvs.2010.01.076.

  PMID: 20435261 BACKGROUND

• Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.

  PMID: 24456716 BACKGROUND

• Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811.

  PMID: 23797811 BACKGROUND

• Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M, Snead DB, Kent KC, Rocha-Singh KJ; IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014 Oct 14;64(15):1568-76. doi: 10.1016/j.jacc.2014.06.1198.

  PMID: 25301459 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonella Biello, MD

  Neuromed IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella Biello, MD

CONTACT

+393287359230; bielloantonella@gmail.com

Francesco Pompeo, MD

CONTACT

+390865929155; pompeofrancesco@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of vascular surgery division

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 15, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 15, 2015

Record last verified: 2015-07