NCT03487432

Brief Summary

The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

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

First Submitted

Initial submission to the registry

March 23, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

March 23, 2018

Last Update Submit

November 21, 2019

Conditions

Calcified Coronary Artery Disease (Grade 3)

Outcome Measures

Primary Outcomes (1)

  • Stent expansion index (SEI)

    Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis

    intraprocedural

Secondary Outcomes (8)

  • Angiographic Success

    intraprocedural

  • Procedural Success

    30 days

  • Strategy Success

    intraprocedural

  • Acute lumen gain,

    intraprocedural

  • Complementary lesion preparations

    intraprocedural

  • +3 more secondary outcomes

Study Arms (2)

OPN NC

EXPERIMENTAL

Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC)

Device: Super High-Pressure NC PTCA Balloon (OPN NC)

NSE Alpha

EXPERIMENTAL

Patients receiving a Scoring PTCA Balloon (NSE Alpha)

Device: Scoring PTCA Balloon (NSE Alpha)

Interventions

Super High-Pressure NC PTCA Balloon (OPN NC)DEVICE

Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty.

OPN NC
Scoring PTCA Balloon (NSE Alpha)DEVICE

Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty.

NSE Alpha

Eligibility Criteria

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

You may qualify if:

  • Age above 18 years and consentable;
  • Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia;
  • Angiographically-proven coronary artery disease;
  • De novo lesion in a native coronary artery;
  • Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation;
  • Calcification of the target lesion as determined by angiography (grade 3);
  • Unsuccessful lesion preparation (\<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty
  • Written informed consent.

You may not qualify if:

  • Myocardial infarction (within 1 week);
  • Limited long-term prognosis due to other conditions;
  • Target lesion is in a coronary artery bypass graft;
  • Target lesion is an in-stent restenosis;
  • Target lesion is aorto-ostial;
  • Target vessel thrombus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

Deutsches Herzzentrum Muenchen

München, Germany

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Robert A Byrne, MD BCh PhD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Salvatore Cassese, MD PhD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 4, 2018

Study Start

July 20, 2018

Primary Completion

September 23, 2019

Study Completion

October 23, 2019

Last Updated

November 22, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)CH(1)