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

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

Study Overview

• Status: Unknown
• Conditions: CAD

• Study Type: Observational
• Enrollment (Anticipated): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery diseases (in-stent restenosis, small vessel diseases, bifurcation lesions, de novo lesions)

Description

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.

Exclusion criteria:

1. Patients with a hypersensitivity to Sirolimus drug or its structural activity related compounds.
2. Patients with a known hypersensitivity to excipients with phospholipid or related origins.
3. Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.
4. Severely calcified lesions requiring treatment of other type for e.g. Rotational Atherectomy (Rotablator)
5. Patients judged to have lesion that prevents complete inflation of angioplasty balloon or proper placement of delivery catheter
6. Patients who cannot receive recommended antiplatelet or anticoagulation therapy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: MINVASYS

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): September 1, 2018

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (ESTIMATE): August 3, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 3, 2016
• Last Update Submitted That Met QC Criteria: July 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: PCI; Bifurcation; Sirolimus; Restenosis; CAD; DCB; DEB; ISR; Coronary artery; SVD
• Other Study ID Numbers: P1601