Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice

Assessment of Safety and Efficacy of the DEVOIR Sirolimus-Coated Balloon for the Treatment of Native Coronary Artery Lesions in the Real-world Clinical Practice

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02853994

Enrollment

500

Registered

2016-08-03

Start date

2016-09-30

Completion date

2018-09-30

Last updated

2016-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CAD

Keywords

DCB, DEB, Sirolimus, PCI, ISR, SVD, Restenosis, Bifurcation, CAD, Coronary artery

Brief summary

The study is a prospective, non-randomized, multicenter, post-marketing surveillance study evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding device approved indications: * In-stent restenosis lesions: either bare metal or drug eluting stent restenosis * Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary arteries * Small vessels: treatment of lesions ≤2.75 mm * BMS implantation followed by DCB inflation

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patient's inclusion and

Exclusion criteria

are per device instructions for use's indications and contraindications. Inclusion criteria: 1. Patient is at least 18 years old 2. Lesion lengths ranging from 8 to 38 mm and diameters ranging from 1.50 mm to 4.00 mm.

Design outcomes

Primary

Measure	Time frame
Rate of Major Adverse Cardiac Events (MACE)	12 months

Secondary

Measure	Time frame
Rate of Target Lesion Revascularization (TLR)	12 months
Rate of Target Vessel Failure (TVF)	12 months
Rate of Target Vessel Revascularization (TVR)	12 months
Angiographic success	Day 1

Outcome results