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

CAD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02853994
• Other study ID #: P1601
• Status: Not yet recruiting
• Phase: N/A
• First received: July 18, 2016
• Last updated: July 29, 2016
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: July 2016
• Source: MINVASYS
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• CAD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MINVASYS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Major Adverse Cardiac Events (MACE)		12 months	Yes
Secondary	Rate of Target Lesion Revascularization (TLR)		12 months	No
Secondary	Rate of Target Vessel Failure (TVF)		12 months	No
Secondary	Rate of Target Vessel Revascularization (TVR)		12 months	No
Secondary	Angiographic success		Day 1	No