NCT02853994

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

July 18, 2016

Last Update Submit

July 29, 2016

Conditions

CAD

Keywords

DCBDEBSirolimusPCIISRSVDRestenosisBifurcationCADCoronary artery

Outcome Measures

Primary Outcomes (1)

  • Rate of Major Adverse Cardiac Events (MACE)

    12 months

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • Patient is at least 18 years old
  • Lesion lengths ranging from 8 to 38 mm and diameters ranging from 1.50 mm to 4.00 mm.
  • Patients with a hypersensitivity to Sirolimus drug or its structural activity related compounds.
  • Patients with a known hypersensitivity to excipients with phospholipid or related origins.
  • Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.
  • Severely calcified lesions requiring treatment of other type for e.g. Rotational Atherectomy (Rotablator)
  • Patients judged to have lesion that prevents complete inflation of angioplasty balloon or proper placement of delivery catheter
  • Patients who cannot receive recommended antiplatelet or anticoagulation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

August 3, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 3, 2016

Record last verified: 2016-07