An interventional study of Evero DCB and Paclitaxel DCB in Peripheral Vascular Disease and Peripheral Arterial Disease, sponsored by Cook Research Incorporated. Recruiting at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Cook Research Incorporated (part of Cook Group Incorporated) · Not applicable, Interventional, and Treatment
The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero drug-coated balloon [DCB]) in the treatment of the femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Specifically, the Randomized-Controlled Trial (RCT) is designed to demonstrate non-inferior safety and non-inferior effectiveness of the Evero DCB when compared to commercially available paclitaxel DCBs (pDCBs).
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 410 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Cook Research Incorporated is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Compared within Peripheral Arterial Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Vascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
General Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with Evero drug-coated balloon to apply local treatment with everolimus
Combination Product: Evero DCB
Treatment with commercially-available drug-coated balloons to apply local treatment with paclitaxel
Combination Product: Paclitaxel DCB
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
Primary safety endpoint
The primary safety endpoint is a composite assessment of freedom from device- or procedure-related death, freedom from target limb major amputation, and freedom from clinically-driven target lesion revascularization (CD-TLR)
Time frame: 30 days (death); 12 months (amputation and CD-TLR)
Primary effectiveness endpoint
The primary effectiveness endpoint is primary patency defined as peak systolic velocity ratio ≤2.4 assessed by duplex ultrasound at 12 months and freedom from CD-TLR.
Time frame: 12 months
Plan to share: Yes — Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access. html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Supporting information: Study protocol
Time frame: Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication.
Access criteria: Qualified scientific researchers
Data sharing details ↗ · www.cookresearchinc.com
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Sep 2028, 29 months after the start.
Of 125 industry-sponsored interventional studies with no phase under Peripheral Arterial Disease, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 45. This study's planned 29 months is close to that.
Counting every sponsor, half of 385 studies reached it within 31 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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