NCT04017364

Brief Summary

To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

August 27, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

July 3, 2019

Last Update Submit

August 24, 2021

Conditions

Coronary Artery Disease

Keywords

drug coated balloonPaclitaxelsirolimus

Outcome Measures

Primary Outcomes (1)

  • late lumen loss in-segment

    angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline

    6 months

Secondary Outcomes (2)

  • Procedural success

    5 days

  • MACE

    at 6 and at 12 months

Study Arms (2)

PTCA of coronary de novo lesion PCB

ACTIVE COMPARATOR

Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²)

Device: PCB PTCA

PTCA of coronary de novo lesion SCB

EXPERIMENTAL

Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)

Device: SCB PTCA

Interventions

PCB PTCADEVICE

Predilatation of coronary de-novo stenosis followed by a PCB

PTCA of coronary de novo lesion PCB
SCB PTCADEVICE

Predilatation of coronary de-novo stenosis followed by a SCB

PTCA of coronary de novo lesion SCB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical evidence of stable or unstable angina or a positive functional study
  • Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with positive functional test or symptom of ischemia)
  • Successful lesion preparation (no flow-limiting dissection or a residual stenosis \> 30%)

You may not qualify if:

  • Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
  • Intolerance and / or allergy to Sirolimus
  • Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:
  • iopromide)
  • Patients with an ejection fraction of \< 30 %
  • Reference vessel diameter (RVD) \< 2.5 mm
  • Contraindication for whichever necessary accompanying medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sabah Heart Centre, Queen Elizabeth Hospital II

Kota Kinabalu, 88300, Malaysia

Location

National Heart Institute

Kuala Lumpur, 50400, Malaysia

Location

Cardio Vascular Sentral

Kuala Lumpur, 50470, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

Location

Sarawak Heart Centre

Kuching, 94300, Malaysia

Location

Hospital Pulau Pinang

Pulau Pinang, 10990, Malaysia

Location

Related Publications (2)

  • Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.

    PMID: 30898253RESULT

  • Ahmad WAW, Nuruddin AA, Abdul Kader MASK, Ong TK, Liew HB, Ali RM, Mahmood Zuhdi AS, Ismail MD, Yusof AKM, Schwenke C, Kutschera M, Scheller B. Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2022 Apr 11;15(7):770-779. doi: 10.1016/j.jcin.2022.01.012. Epub 2022 Mar 16.

    PMID: 35305906DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 12, 2019

Study Start

July 1, 2019

Primary Completion

August 30, 2020

Study Completion

January 31, 2021

Last Updated

August 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

MY(6)