NCT03908450

Brief Summary

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

Trial Health

90
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 Sep 2019

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
2 countries

4 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

First Submitted

Initial submission to the registry

April 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

3.6 years

First QC Date

April 2, 2019

Last Update Submit

February 14, 2024

Conditions

Coronary Artery Disease

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

    in hospital

  • MACE MACE

    at 6 and at 12 months

Study Arms (2)

Control intervention

ACTIVE COMPARATOR

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

Device: PTCA of coronary de novo lesion PCB

Experimental intervention

EXPERIMENTAL

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

Device: PTCA of coronary de novo lesion SCB

Interventions

PTCA of coronary de novo lesion PCBDEVICE

PTCA of coronary de novo lesion with drug coated balloon

Control intervention
PTCA of coronary de novo lesion SCBDEVICE

PTCA of coronary de novo lesion with drug coated balloon

Experimental intervention

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 (4)

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Homburg/Saar, Saarland, 66421, Germany

Location

Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Klinik für Innere Medizin III - Kardiologie Paul Gerhardt Stift

Wittenberg, 06886, Germany

Location

Universitätsspital Basel

Basel, 4031, Switzerland

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: 30898253BACKGROUND

  • Scheller B, Mangner N, Jeger RV, Afan S, Mahfoud F, Woitek FJ, Fahrni G, Schwenke C, Schnorr B, Kleber F. A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions. EuroIntervention. 2024 Nov 4;20(21):e1322-e1329. doi: 10.4244/EIJ-D-23-00868.

    PMID: 39492703DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bruno Scheller, MD

    Clinical and Experimental Interventional Cardiology, University of Saarland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
angiographies blinded to treatment groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomization
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 9, 2019

Study Start

September 25, 2019

Primary Completion

April 30, 2023

Study Completion

July 31, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)CH(1)