Α Pre CE-Marking Study Using the Rontis Drug Coated Balloon for Treatment of Lesions in Femoropopliteal Arteries

NCT04821388 | Unknown

• 1 other identifier: RONTIS 59/2015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

The Rontis Drug Coated - Peripheral Balloon Catheter is intended for PTA procedure on atherosclerotically stenotic or obstructed vessels and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae in order to improve the perfusion and decrease the incidence of restenosis. In this study, it is intended to use Rontis DCB for treatment of lesions in the femoropopliteal arteries.

Conditions

Peripheral Artery Disease (PAD)

Outcome Measures

Primary Outcomes (1)

• Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization (TVR) at 30 days

  Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization (TVR) at 30 days

  30 days

Secondary Outcomes (11)

• Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization (TVR) at 12 months

  12 months

• Late Lumen Loss (LLL)

  6 months post procedure

• Primary patency at 12 months

  12 months

• Procedural success

  Immediately after intervention

• Technical success

  Immediately after intervention

Study Arms (1)

intended to use Rontis DCB for treatment of lesions in the femoropopliteal arteries.

EXPERIMENTAL

Device: Rontis DCB

Interventions

Rontis DCB DEVICE

The Rontis DCB is intended for use as a percutaneous transluminal angioplasty (PTA) catheter to dilate stenotic or obstructive vascular lesions in the lower extremities for the purpose of improving limb perfusion and decreasing the incidence of restenosis. In this study, it is intended to use Rontis DCB for treatment of lesions in the femoropopliteal arteries

intended to use Rontis DCB for treatment of lesions in the femoropopliteal arteries.

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years;
• The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF);
• Rutherford Category 2-4;
• Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of ≥70% stenosis or occlusion (by visual estimate) and is amenable to treatment with Rontis DCB;
• Patients must be able to be treated with Rontis DCB;
• Total Rontis DCB treated segment(s) of 3-15 cm in length;
• Target vessel reference diameter is 4.0-6.0 mm (by visual estimate) and able to be treated with available device size;
• At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography
• No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
• Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
• Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the tibioperoneal trunk.

You may not qualify if:

• Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
• Contraindication to Rontis DCB per current manufacturer's IFU;
• Life expectancy of \<1 year;
• Inability to take required antiplatelet/anticoagulant medications, or known contraindication (including allergic reaction) or sensitivity to contrast media that cannot be adequately managed with pre- and post-procedure medication; hypersensitivity to paclitaxel
• Intended treatment of outflow disease during the index procedure;
• Use of adjuvant therapies i.e. laser, atherectomy, cryoplasty or brachytherapy during index procedure;
• Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
• History of hemorrhagic stroke within 3 months;
• History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
• Participation in an investigational drug or another investigational device study until this study's primary endpoint is reached or previous enrollment in this study;
• Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the CIP or confound data interpretation;
• Target vessel and/or lesion involves a previously placed stent.

Sponsors & Collaborators

• Rontis Hellas SA: lead
• Pharmassist Ltd: collaborator

Study Sites (5)

General Hospital of Thessaloniki "G. Gennimatas"

Thessaloniki, Macedonia, 54635, Greece

Location

University General Hospital of Patras,

Pátrai, Rio, 26504, Greece

Location

Uniiversity Hospital of Larisa

Larissa, Thessaly, Greece

Location

251 Airforce General Hospital

Athens, 11525, Greece

Location

University General Hospital Attikon

Athens, 12462, Greece

Location

Related Publications (13)

• Bunte MC, Shishehbor MH. Next Generation Endovascular Therapies in Peripheral Artery Disease. Prog Cardiovasc Dis. 2018 Mar-Apr;60(6):593-599. doi: 10.1016/j.pcad.2018.03.003. Epub 2018 Mar 10.

  PMID: 29534985 RESULT

• Conte SM, Vale PR. Peripheral Arterial Disease. Heart Lung Circ. 2018 Apr;27(4):427-432. doi: 10.1016/j.hlc.2017.10.014. Epub 2017 Nov 7.

  PMID: 29150158 RESULT

• Zeller T. Current state of endovascular treatment of femoro-popliteal artery disease. Vasc Med. 2007 Aug;12(3):223-34. doi: 10.1177/1358863X07079823.

  PMID: 17848483 RESULT

• Levy PJ. Epidemiology and pathophysiology of peripheral arterial disease. Clin Cornerstone. 2002;4(5):1-15. doi: 10.1016/s1098-3597(02)90012-8.

  PMID: 12425180 RESULT

• Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.

  PMID: 18272892 RESULT

• Herten M, Torsello GB, Schonefeld E, Stahlhoff S. Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease. Vasc Health Risk Manag. 2016 Aug 29;12:341-56. doi: 10.2147/VHRM.S81122. eCollection 2016.

  PMID: 27621646 RESULT

• Endovascular Today. The Iliac/SFA/Popliteal Center. DCBs available in Europe. https://evtoday.com/device-guide/europe/chart.asp?id=159

  RESULT

• Al-Bawardy RF, Waldo SW, Rosenfield K. Advances in Percutaneous Therapies for Peripheral Artery Disease: Drug-Coated Balloons. Curr Cardiol Rep. 2017 Aug 24;19(10):99. doi: 10.1007/s11886-017-0913-3.

  PMID: 28840466 RESULT

• Coyne KS, Margolis MK, Gilchrist KA, Grandy SP, Hiatt WR, Ratchford A, Revicki DA, Weintraub WS, Regensteiner JG. Evaluating effects of method of administration on Walking Impairment Questionnaire. J Vasc Surg. 2003 Aug;38(2):296-304. doi: 10.1016/s0741-5214(03)00312-4.

  PMID: 12891111 RESULT

• Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.

  PMID: 17377972 RESULT

• Hardman RL, Jazaeri O, Yi J, Smith M, Gupta R. Overview of classification systems in peripheral artery disease. Semin Intervent Radiol. 2014 Dec;31(4):378-88. doi: 10.1055/s-0034-1393976.

  PMID: 25435665 RESULT

• Brodmann M, Keirse K, Scheinert D, Spak L, Jaff MR, Schmahl R, Li P, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2113-2123. doi: 10.1016/j.jcin.2017.06.018.

  PMID: 29050631 RESULT

• Mahe G, Ouedraogo N, Vasseur M, Faligant C, Saidi K, Leftheriotis G, Abraham P. Limitations of self-reported estimates of functional capacity using the Walking Impairment Questionnaire. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):104-9. doi: 10.1016/j.ejvs.2010.10.002. Epub 2010 Nov 30.

  PMID: 21123095 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: March 29, 2021
• Study Start: January 11, 2019
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (5)