Drug-coated Balloon Treatment in Coronary Lesions

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-10

Study Completion Date

2025-02-10

Brief Summary

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This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions

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Detailed Description

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The treatment of coronary lesions triggers processes in vessel walls with different characteristics depending on the revascularization strategy, post-traumatic healing following plain balloon angioplasty triggers vessel recoil and neointimal overgrowth, bare metal or drug eluting stent implantation results in neointimal cell proliferation, scar tissue formation, and ultimately, the generation of neoatherosclerosis Drug-coated balloons(DCBs) were presented two decades ago as an alternative to plain-balloon inﬂation or subsequent stent implantation in order to overcome in-stent restenosis.Recently, there has been growing evidence that DCBs can also be used off-label to treat de novo lesions in small vessels Therefore, the aim of this study is to evaluate efﬁcacy and safety of drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions

Conditions

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Drug-coated Balloon

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type EXPERIMENTAL

Angioplasty

Intervention Type DEVICE

Drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions

Interventions

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Angioplasty

Drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Eligible patients are those with lesions in the coronary vessel tree who will be planned to be treated with drug coated balloon.

Exclusion Criteria

1. Severe renal impairment ( Cr.Cl. \< 45 ml/min ).
2. Sever heart failure or liver cell failure .
3. Patients with contraindications to coronary angiography or invasive procedures.
4. Known allergy or intolerance to the medications or devices commonly used during PCI procedures.
5. Severe comorbidities or conditions that may limit life expectancy or impact the ability to follow the study protocol.
6. Pregnant or lactating women.

Eligible Sex

ALL

Accepts Healthy Volunteers

No