Status:
UNKNOWN
Α Pre CE-Marking Study Using the Rontis Drug Coated Balloon for Treatment of Lesions in Femoropopliteal Arteries
Lead Sponsor:
Rontis Hellas SA
Collaborating Sponsors:
Pharmassist Ltd
Conditions:
Peripheral Artery Disease (PAD)
Eligibility:
All Genders
18+ years
Phase:
NA
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 synth...
Detailed Description
Peripheral artery disease (PAD) is an increasingly common and serious cardiovascular disease attributable to substantial morbidity, mortality, and health status impairment. The condition describes a s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04821388
Start Date
January 11 2019
End Date
August 30 2021
Last Update
March 29 2021
Active Locations (5)
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1
General Hospital of Thessaloniki "G. Gennimatas"
Thessaloniki, Macedonia, Greece, 54635
2
University General Hospital of Patras,
Pátrai, Rio, Greece, 26504
3
Uniiversity Hospital of Larisa
Larissa, Thessaly, Greece
4
251 Airforce General Hospital
Athens, Greece, 11525