NCT02996318

Brief Summary

The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

5 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

December 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 9, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

December 9, 2016

Last Update Submit

August 24, 2021

Conditions

DES In-stent Stenosis

Outcome Measures

Primary Outcomes (1)

  • Late lumen loss

    Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI

    6 months

Secondary Outcomes (2)

  • Procedural Success

    24 hours

  • MACE (Major adverse cardiac events)

    12 months

Study Arms (2)

Sirolimus coated Balloon

EXPERIMENTAL

treatment of coronary DES-ISR with a sirolimus coated balloon

Device: Sirolimus coated balloon

Paclitaxel coated balloon (SeQuent Please)

ACTIVE COMPARATOR

treatment of coronary DES-ISR with a paclitaxel coated balloon

Device: Paclitaxel coated balloon (SeQuent Please)

Interventions

Paclitaxel coated balloon (SeQuent Please)DEVICE

Paclitaxel coated balloon (SeQuent Please)

Paclitaxel coated balloon (SeQuent Please)
Sirolimus coated balloonDEVICE

Sirolimus coated balloon

Sirolimus coated Balloon

Eligibility Criteria

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

You may qualify if:

  • years of age
  • Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study
  • Patients with ≤ 2 primary drug-eluting stent in-stent restenosis (DES-ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥ 50% and positive functional study) including margin stenosis with max 5mm distance to the stent.

You may not qualify if:

  • Chronic renal insufficiency with serum creatinine levels \> 2.0 mg per deciliter
  • Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication
  • Concomitant medical illness associated with a life-expectancy of less than two year
  • Lesion length (ISR) \> 35 mm, vessel diameter \< 2.5 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Queen Elizabeth Hospital II

Kota Kinabalu, 88300, Malaysia

Location

National Heart Institute

Kuala Lumpur, 50400, Malaysia

Location

University Malaya

Kuala Lumpur, 50603, Malaysia

Location

Sarawak Genaral Hospital Heart Centre

Kuching, 94300, Malaysia

Location

Hospital Pulau Pinang

Pulau Pinang, 10990, Malaysia

Location

Related Publications (2)

  • Scheller B, Mangner N, Abdul Kader MASK, Wan Ahmad WA, Jeger R, Wohrle J, Ong TK, Liew HB, Gori T, Mahfoud F, Nuruddin AA, Woitek F, Abidin IZ, Schwenke C, Schnorr B, Mohd Ali R. Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions. Circ Cardiovasc Interv. 2022 Sep;15(9):e012305. doi: 10.1161/CIRCINTERVENTIONS.122.012305. Epub 2022 Sep 20.

    PMID: 36126132DERIVED

  • 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: 30898253DERIVED

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

December 9, 2016

First Posted

December 19, 2016

Study Start

December 1, 2015

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

MY(5)