Brasilianskt prospektivt register för Inspiron EVO-läkemedelsavgivande stent i komplexa kranskärlsläsioner (PCI EVOlution)
Nationellt prospektivt register för Inspiron EVO läkemedelsavgivande stent vid komplexa kranskärlsläsioner
The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population. Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions will be treated with the Inspiron™ EVO drug-eluting stent.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Post-marketing, observational, prospective, multi-center, non-randomized, single-arm registry that will include all patients who receive the Inspiron™ EVO stent at participating sites and meet the eligibility criteria.
Up to 2,000 patients are expected to be enrolled across 12 research sites in Brazil. Participants' demographic, procedural, and follow-up data will be collected for up to 12 months in this study.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Marco Aurélio A Costa, MD, PhD
- Telefonnummer: +1 216 903-9327
- E-post: marco.costa@scitechmed.com
Studera Kontakt Backup
- Namn: Ana Paula B Pellaquim, MSc.
- Telefonnummer: +55 62 9471-4439
- E-post: aalmeida@scitechmed.com
Studieorter
-
-
Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90610000
- Rekrytering
- Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
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Kontakt:
- Paulo Ricardo A Caramori, MD
- Telefonnummer: +55 51 99982 0766
- E-post: caramori@cardiarte.com.br
-
Kontakt:
- Rosa Homem
- Telefonnummer: +55 51 99679 8040
- E-post: cer.pesquisaclinica@gmail.com
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions treated with the Inspiron™ EVO Drug-Eluting Stent.
Beskrivning
Inclusion Criteria:
- Individuals aged 18 years or older presenting with complex coronary lesions requiring percutaneous coronary intervention (PCI).
- Individuals who provide consent and are willing to comply with the follow-up protocol.
- Individuals who received treatment with the Inspiron™ EVO Stent.
- Individuals with lesions ≥ 30 mm in length (Subprotocol 1).
- Individuals with significantly calcified coronary lesions (moderate to severe according to the ACC/AHA classification B1, B2, or C), with or without indication for lesion preparation techniques (Subprotocol 2).
- Individuals with multivessel coronary artery disease (≥2 affected coronary vessels, with at least one vessel of small diameter ≤2.5 mm) (Subprotocol 3).
- Individuals included in Subprotocol 1, 2, or 3. The evaluated segment must be accessible to the IVUS (Intravascular Ultrasound) catheter (Subprotocol 4).
Exclusion Criteria:
- Lesions in saphenous vein grafts or internal mammary grafts.
- Contraindication to the use of a drug-eluting stent.
- Individuals who were treated during the index procedure with any stent other than the Inspiron™ EVO Stent.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Experimental: Percutaneous coronary intervention (PCI)
Patients with symptomatic ischemic heart disease due to lesions in the native coronary artery and restenotic lesions treated with the Inspiron™ EVO drug-eluting stent. |
Percutaneous coronary intervention (PCI) using the Inspiron EVO Drug-Eluting Stent, which has a reduced crimped profile, providing greater safety and facilitating lesion crossing. In addition, the design is optimized to provide increased radial strength. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Device success
Tidsram: Initial procedure
|
Device success (at the lesion level) is defined as the successful delivery, balloon expansion, and implantation of the first device at the target lesion (with multiple attempts using the same device permitted), successful withdrawal of the delivery system, and achievement of a final in-stent residual stenosis of <20% |
Initial procedure
|
|
Acute Clinical Success of Percutaneous Coronary Intervention (PCI)
Tidsram: Up to 24 hours
|
Defined as the absence of major adverse in-hospital cardiac events (death, myocardial infarction, or repeat coronary revascularization of the target lesion). |
Up to 24 hours
|
|
MACE (Major Adverse Cardiac Events) rate
Tidsram: 12 months
|
Defined as the combination of cardiac death, myocardial infarction (MI), or revascularization of the target lesion (TLR). |
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Target Lesion Revascularization (TLR) rate
Tidsram: 12 months
|
TLR is defined as any percutaneous reintervention of the target lesion, including the 5 mm proximal and 5 mm distal segments of the stent, or revascularization of the target vessel, performed for clinical reasons due to restenosis or occlusion of the target lesion. |
12 months
|
|
Target vessel revascularization rate (TVR)
Tidsram: 12 months
|
TVR is defined as revascularization of any segment of the target coronary artery. |
12 months
|
|
Target Vessel Failure Rate (TVF)
Tidsram: 12 months
|
Defined as a combination of MI, TLR, or cardiovascular death related to the target vessel. If it is not possible to determine with certainty whether the MI or death was related to the target vessel, the case is considered a TVF. |
12 months
|
|
Rate of definite, probable, and possible stent thrombosis (ST)
Tidsram: 12 months
|
Stent thrombosis is classified as definite, probable, or possible: definite requires angiographic or pathological confirmation; probable includes unexplained death within 30 days or myocardial infarction related to the stented territory without angiographic confirmation; and possible refers to any unexplained death occurring from 30 days after implantation until the end of follow-up. |
12 months
|
|
Cardiovascular mortality
Tidsram: 12 months
|
Any death due to an immediate cardiac cause (e.g., myocardial infarction, low-output heart failure, fatal arrhythmia), unwitnessed death, death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. |
12 months
|
|
Late in-segment luminal loss (including the in-stent portion and the 5-mm proximal and distal edges)
Tidsram: 6 months
|
Defined as the difference between the in-segment minimum luminal diameter (MLD) (including the in-stent portion and the 5-mm proximal and distal edges) after the procedure and the MLD at the 6-month follow-up, as determined by quantitative angiography. |
6 months
|
|
Percent Area Stenosis (%AS)
Tidsram: 6 months
|
Defined as the ratio between the neointimal hyperplasia area and the stent area multiplied by 100 at the 6-month follow-up. |
6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Paulo Ricardo A Caramori, MD, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SCI-EV-001
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