Efficacy and Safety of Paclitaxel-eluting Balloons for Below the Knee Peripheral Arterial Disease

NCT02772224 | Unknown Phase 1

• 1 other identifier: 425008534
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing the efficacy and safety of drug-eluting balloons (DEB) for the treatment of below-the-knee peripheral arterial occlusive disease with conventional balloon angioplasty (BA).

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Restenosis rate

  The primary study endpoint was the occurrence of \> 50% of restenosis in the treated vessel after 12 months as assessed by digital substraction angiography (DSA).

  12 months

• Peak systolic velocity ratio

  Peak systolic velocity ratio ≥ 2.4 by Doppler's ultrasonography was the end point of the study for the patient who did not undergo angiography after 12 months.

  12 months

Secondary Outcomes (3)

• Rutherford scale

  Immediately after procedure

• ABI value

  Immediately after procedure

• Residual stenosis

  Immediately after procedure

Study Arms (2)

Drug eluting balloon angioplasty

EXPERIMENTAL

Paclitaxel coated balloon angioplasty

Device: Drug eluting balloon angioplasty

Conventional balloon angioplasty

ACTIVE COMPARATOR

Conventional balloon angioplasty

Device: Conventional balloon angioplasty

Interventions

Drug eluting balloon angioplasty DEVICE

In the DEB group, the guide wire will be passed through the occluded or stenosed lumen and the predilatation of the target lesion with standard balloon(s) will be performed before dilatation with a paclitaxel-eluting balloon of the diameter, at least about that of the pre-dilatation balloon (Arteryguard, Rientech, Dezhou, China). The drug eluting balloons will then be inflated according to the manufacturer recommendations. The patients will then be followed every six months for a year to compare its treatment efficacy and safety with that of conventional balloon angioplasty group.

Drug eluting balloon angioplasty

Conventional balloon angioplasty DEVICE

The guide wire will be passed through the occluded or stenosed lumen and the conventional balloons will be inflated as recommended by the manufacturer. The primary and secondary outcome will then be assessed and compared with DEB group, on follow up at six and 12 months.

Conventional balloon angioplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Peripheral vascular disease with or without diabetes.
• Rutherford class 2-6.
• Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.
• Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.
• Written informed consent signed by the patients or representatives

You may not qualify if:

• Previous bypass surgery or stent placement at the ipsilateral lower limb
• History of intolerance to antiplatelet therapy, heparin, or contrast media.
• Bleeding diathesis;
• Active systemic bacterial infection;
• Severely impaired renal function (serum creatinine level \> 2.5 mg/dL.
• Expected survival time of less than 24 months

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth people's hospital, Tongji university

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (5)

• 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 RESULT

• Karnabatidis D, Spiliopoulos S, Katsanos K, Siablis D. Below-the-knee drug-eluting stents and drug-coated balloons. Expert Rev Med Devices. 2012 Jan;9(1):85-94. doi: 10.1586/erd.11.67.

  PMID: 22145843 RESULT

• Jens S, Conijn AP, Koelemay MJ, Bipat S, Reekers JA. Randomized trials for endovascular treatment of infrainguinal arterial disease: systematic review and meta-analysis (Part 2: Below the knee). Eur J Vasc Endovasc Surg. 2014 May;47(5):536-44. doi: 10.1016/j.ejvs.2014.02.012. Epub 2014 Mar 17.

  PMID: 24650395 RESULT

• Schnorr B, Albrecht T. Drug-coated balloons and their place in treating peripheral arterial disease. Expert Rev Med Devices. 2013 Jan;10(1):105-14. doi: 10.1586/erd.12.67.

  PMID: 23278227 RESULT

• Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M; IN.PACT DEEP Trial Investigators. IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial. Trials. 2014 Feb 19;15:63. doi: 10.1186/1745-6215-15-63.

  PMID: 24552184 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Maoquan Li, Ph.D

CONTACT

02166313506; cjr.limaoquan@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.Li

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: May 13, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)