NCT03242096

Brief Summary

Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter

Trial Health

90
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 Jul 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

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

July 21, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
6 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

August 1, 2021

Enrollment Period

3 years

First QC Date

July 31, 2017

Last Update Submit

August 24, 2021

Conditions

Coronary Restenosis

Outcome Measures

Primary Outcomes (1)

  • late lumen loss in-lesion at 6 months

    late lumen loss in-lesion at 6 months assessed by blinded QCA

    6 months

Secondary Outcomes (3)

  • Procedural Success

    during hospital stay of index procedure

  • MACE

    6 and 12 months

  • Individual clinical endpoints

    6 and 12 months

Study Arms (2)

Sirolimus coated balloon

EXPERIMENTAL

Treatment of in-stent restenosis with a sirolimus coated balloon

Combination Product: Sirolimus coated balloon

Paclitaxel coated balloon

ACTIVE COMPARATOR

Treatment of in-stent restenosis with a paclitaxel coated balloon

Combination Product: Paclitaxel coated balloon

Interventions

Sirolimus coated balloonCOMBINATION_PRODUCT

Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a sirolimus coated balloon (SeQuent®SCB balloon with sirolimus 4.0 μg/mm²)

Sirolimus coated balloon
Paclitaxel coated balloonCOMBINATION_PRODUCT

Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a paclitaxel coated balloon (SeQuent®Please balloon or SeQuent®Please NEO balloon with paclitaxel 3.0 μg/mm²) (paclitaxel 3.0 μg/mm²)

Paclitaxel 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 in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥50% and positive functional study) including margin-stenosis with max 5 mm 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, reference vessel diameter \< 2.5 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Clinical and Experimental Interventional Cardiology

Homburg, Saarland, 66421, Germany

Location

Klinik für Innere Medizin und Kardiologie

Dresden, 01307, Germany

Location

Deutsches Zentrum für Herz und Kreislauf

Mainz, 55131, Germany

Location

Dept. of Internal Medicine II

Ulm, Germany

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Related Publications (2)

  • Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.

    PMID: 17101615RESULT

  • 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

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary StenosisCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Bruno Scheller, MD

    University of Saarland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded QCA for primary outcome
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental intervention: Predilatation of coronary ISR with POBA followed by a sirolimus coated SeQuent® SCB balloon balloon (sirolimus 4.0 μg/mm²) Control intervention: Predilatation of coronary ISR with POBA followed by a paclitaxel coated SeQuent® Please balloon or SeQuent® Please NEO balloon (paclitaxel 3.0 μg/mm²)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 8, 2017

Study Start

July 21, 2017

Primary Completion

August 1, 2020

Study Completion

January 31, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)CH(1)