Support C Post-Market Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

281 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-09

Study Completion Date

2029-02-28

Brief Summary

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To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Support C Drug Coated Balloon (DCB) in routine clinical practice.

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Detailed Description

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This multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (PCI) and are intended to be or treated by the Support C Drug Coated Balloon (DCB) according to the Instructions for Use as part of routine clinical care. Approximately 278 patients from 8-12 centers in Europe will be entered into the registry. Patients in the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up.

A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.

Conditions

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Coronary Arteriosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Drug Eluting SUPPORT C PTCA balloon catheter

The Drug Eluting SUPPORT C PTCA balloon catheter is indicated for use in patients with symptomatic ischaemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Consecutive patients intended to be, or treated by Support C DCB as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry.

Note:

1. In case of major dissection requiring bailout stenting after DCB use the patients will be included in the registry and followed as per study schedule.
2. If major dissection occurred after lesion preparation, but before DCB use and lesion was stented, the patient will not be included in the registry.

Exclusion Criteria

* Patients are excluded if ANY of the following additional conditions apply:

* High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
* Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
* A life expectancy of \<1year
* Explicit refusal of participation in the registry

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No