Drug-coatEd Balloon Multicentric Registry in Spain and PORTugal (DESPORT)

March 13, 2026 updated by: Portuguese Association of Interventional Cardiology

Drug-eluting stents (DES) have been the main treatment option for coronary angioplasty (PCI) for many years. The antiproliferative drug in DES has the effect of preventing in-stent restenosis, which is typically a consequence of intimal hyperplasia, a characteristic phenomenon of bare metal stents (BMS).

DES have shown to be safe and effective in many clinical and anatomical scenarios. There are, however, several caveats to DES, like restenosis, thrombosis, accelerated atherosclerosis, impossibility of surgical revascularization and disruption of vessel dynamics.

These phenomena have a very meaningful negative impact on patient outcomes. Drug-coated balloons (DCB) may avoid those limitations of DES and are an appealing alternative in many different scenarios. They have been the mainstay treatment of in-stent restenosis (ISR) and were formally recommended for this setting in internationally, although recent guidelines recommend DES over a DCB for a first DES restenosis. There is, however, solid evidence for their use in the context of any ISR (BMS or DES-related) and both comparing with POBA or DES. The presence of metal from previous stents makes the implantation of more stents even more of a thing to avoid.

High bleeding risk may also be an advantageous setting for DCB, as it may allow for a shorter or less intensive anti-thrombotic treatment with the same or even improved safety endpoints when compared to BMS or DES with standard therapy.

Other than ISR, there are other particularly appealing anatomical settings for DCBs such as bifurcations, small vessels and diffuse disease. In the setting of a bifurcation where only the side branch is to be treated, there is evidence that DCB is a good option and provides significantly less late luminal loss when compared to POBA. In case a stent is used in the main branch, a DCB is also a good option for the side branch.

In small vessels (<3,0mm), in which the stent metal would be more conspicuous relative to the smaller lumen, there is strong evidence pointing to a benefit of DCB when compared to balloon angioplasty (POBA) and results at least as good as full-DES. A similar MACE rate between DCB and DES has been reported, with a benefit for DCB in terms of bleeding. In fact, also in larger vessels, DCB may lead to similarly good outcomes. DCB (alone or in combination with DES) is a good alternative to DES-only in diffuse disease.

Provided that a good lesion preparation is achieved and there is no structural compromise to the vessel, the lack of a metal stent will be of benefit for any type of lesion. It will contribute to late lumen enlargement (LLE), which can happen in 40-56% of lesions treated with DCB7 and is associated with layered plaques by OCT and medial dissection after lesion preparation.

Evidence for DCBs is increasing in different anatomical and clinical contexts, and there are some dedicated recommendations and consensus regarding their use. There is some data regarding real-world clinical performance of DCBs, but there is still the need for large real-world studies with different DCBs, techniques, clinical settings and anatomical contexts with long term follow-up, which is the main driver for this registry.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing percutaneous coronary intervention (PCI) in which a drug-coated balloon (DCB) is used in at least one coronary lesion.

Description

Inclusion Criteria:

  1. Patient over the age of 18 years, undergoing PCI with at least one DCB attempted.
  2. Patient has provided written informed consent as approved by the Ethics Committee (EC)
  3. Patient is willing to undergo all registry procedures and follow-up requirements

Exclusion Criteria:

  1. Patients with known allergy to antiplatelet drugs or DCB antiproliferative agents
  2. Life expectancy less than 12 months
  3. Cardiogenic shock
  4. Left ventricular ejection fraction < 15%.
  5. Any condition, which in the investigator opinion, would preclude safe participation of the patient in the registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF)
Time Frame: 2 Years

Target Lesion Failure (TLF) defined as a composite of:

  1. Cardiac Death
  2. Target vessel Myocardial infarction (MI)
  3. Clinically driven target lesion revascularization (TLR)
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy Endpoints
Time Frame: 30 days and 2 Years
  1. Target lesion revascularization (TLR)
  2. Target vessel revascularization (TVR)
30 days and 2 Years
Safety Endpoints
Time Frame: 2 Years

  1. Major Adverse Cardiovascular Events (MACE) defined as a composite of :

    1. All-cause mortality
    2. MI (target-vessel and non-target-vessel MI)
    3. Clinically driven TLR
  2. All-cause mortality
  3. Cardiovascular mortality
  4. Myocardial infarction
  5. Stroke (ischemic or haemorrhagic)
  6. Acute kidney injury (AKI)
  7. Major bleeding
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portuguese Association of Interventional Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DESPORT-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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