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Safety and Efficacy of the DE...

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

Last Updated: 2016-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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CAD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers