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

Minvasys

Status: Unknown

Conditions: CAD

Study type: Observational

Funder types: Industry

Identifiers

NCT02853994

P1601

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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.