Health TrialsbyHealthPanel

Prevail Global Study

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronic Vascular

About this trial

The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years

Negative pregnancy test

Stable or unstable angina, positive functional test, or stable NSTEMI

Life expectancy >1 year

Disqualifiers

Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated

History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative

Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³

Renal insufficiency (or failure)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prevail DCB

    Device

    The Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR) and to treat de novo lesions in small vessel disease.

  • Agent DCB

    Device

    The Agent Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR).

Treatment groups

1,205 Participants
are divided into 2 treatment groups
Group A: ISR Cohort Prevail DCBExperimental treatment 2 interventions
Group B: DNSV Cohort (RVD 2.0 - 2.75mm)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ISR Cohort Primary Analysis

The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority

Time frame
1 year post-procedure
2

DNSV Cohort Primary Analysis

The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control

Time frame
1 year post-procedure

Secondary outcomes

1

Acute success

Acute success (device, lesion, and procedure) through hospital discharge only

Time frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
2

All deaths

Time frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
3

Cardiac death

Time frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
4

All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)

Time frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medtronic Vascular

Lead sponsor

Source ClinicalTrials.gov
Apply now