A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Clinical Trial Evaluating the Safety and Efficacy of Single-use Peripheral Intravascular Shock Wave Catheters Combined With Intravascular Shock Wave Therapy Devices for Peripheral Artery Calcified Lesions.
This trial is a prospective, multicenter, randomized, parallel controlled clinical trial. It to recruit patients with peripheral arterial calcified lesions, who will be randomly assigned in a 1:1 ratio to either the group or the control group. Subjects in the experimental group will use a disposable intra-peripheral vascularwave catheter combined with an intravascular shockwave therapy device to treat peripheral arterial calcified lesions and perform balloon dilation, while subjects in the control group will use a peripheral balloon dilation catheter to treat peripheral arterial calcified lesions and perform balloon dilation.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Lu Xinwu Principal Investigator
- Telefonnummer: 86-21-23271699
- E-Mail: luxw1654@sh9hospital.org.cn
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
General selection criteria
- Age 18 to 80 years old, regardless of gender;
- Rutherford grade is 2 to 5
- As judged by the investigator, peripheral endovascular treatment is required;
- The subject or their legal guardian has been informed of the purpose of the trial, consents to participate and signs the informed consent form;
- The subject is willing comply with all assessment requirements in the trial;
Inclusion criteria for angiography:
1) Target lesions are vascular calcified lesions of grade Ⅲ to Ⅳ according to PARC classification: 2 Target lesions are located in native femoral artery and/or popliteal artery; 3) Total of target lesion ≤260mm; if it contains occlusive lesion, length of occlusive segment ≤100mm and total length of target lesion ≤20mm; 4) Target lesions have not undergone any surgical interventions including endovascular therapy and open surgery before, and the stenosis degree target lesion is ≥70% (visual assessment); 5) Reference vessel diameter of target is between 2.5mm and 8.0mm; 6) At least one distal outflow tract of target lesion is (vascular stenosis degree ≤50% by visual assessment), with blood flow reaching foot (not dependent on collateral circulation); or the patient has successfully undergone treatment for target lesion before (i.e., residual stenosis degree ≤30% by visual assessment after treatment, without serious complications); 7) The ipsilateral inflow tract of target lesion is patent (vascular stenosis degree ≤50% by visual assessment), or the patient has successfully undergone treatment for lesion before (i.e., residual stenosis degree ≤30% by visual assessment treatment, without serious complications);
Exclusion Criteria:
General Exclusion Criteria
- History of amputation of target limb or planned major amputation (above the ankle
- INR > 3 or platelet count < 60×10^9/L;
- Patients with known renal insufficiency (ser creatinine >2.5 mg/dL or 220 μmol/L) or renal failure requiring long-term dialysis;
- Patients with known contraindications to antiplatelet andagulant therapy;
- Patients with known allergies to contrast agents used in endovascular therapy and experimental device materials;
- Patients who have receivedbolytic therapy in the target vessel within 14 days prior to signing informed consent; ) Patients who have experienced myocardial infarction within 60 days prior to signing informed consent;
8) Patients who have experienced stroke within 60 days prior to signing informed consent; 9) Women of childbearing age who are pregnant, breastfeeding or planning pregnancy; 10) Patients participating in other medical device or drug clinical trials; 11) Other reasons considered by the investigator as inappropriate for participation in the trial.
Angiography exclusion criteria:
- The target vessel has evidence of aneurysm or acute/chronic thrombosis;
- The vessel is highly tortuous (the visual arc is greater than 30°);
- The guidewire cannot pass through the target lesion; 4 There is in-stent restenosis in the target lesion area;
5) Before treating the lesion with research devices, ablative devices such as cutting balloons, scoring balloons, compliant balloons, mammillary balloons, pronged balloons, plaque excision devices, excimer laser systems, and peripheral throm aspiration catheters need to be used.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: experimental group
The subjects in the experimental group used disposable peripheral intravascular shockwave catheters with intravascular shockwave therapy devices to treat peripheral artery calcification lesions and perform balloon dilatation. |
The subjects in the experimental group used disposable peripheral intravascular shockwave catheters combined with intravascular shockwave therapy devices to treat peripheral artery calcification lesions and perform balloon dilatation. |
|
Experimental: control group
The subjects in the control group used peripheral balloon dilatation catheters to treat artery calcified lesions and conduct balloon dilatation. |
The subjects in the control group used peripheral balloon dilatation catheters to treat peripheral artery calcified lesions and conduct balloon dilatation. |
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Technical success rate
Zeitfenster: immediately after surgery
|
After treatment with the investigational device, residual diameter stenosis of the target lesion is ≤0% and no dissection of grade ≥D is present. |
immediately after surgery
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Device success rate
Zeitfenster: immediately after surgery
|
The interventional device successfully reached the lesion site, achieved successful expansion without any rupture, was successfully withdrawn. |
immediately after surgery
|
|
Primary patency rate of target lesions at 30 days after operation
Zeitfenster: 30 days after operation
|
No clinically driven target lesion revascularization (CD-TLR) and no target lesionosis detected by imaging examinations |
30 days after operation
|
|
Changes in ankle-brachial index at 7 days postoperatively or on the day discharge, and at 30 days postoperatively.
Zeitfenster: 7 days post-operation or the day of discharge, 30 days post-operation
|
7 days post-operation or the day of discharge, 30 days post-operation
|
|
|
Changes in Rutherford grade at 7 days postoperatively or discharge day, 3 days postoperatively, and 6 months postoperatively
Zeitfenster: 7 days after surgery or discharge date, 30 days after surgery, 6 months surgery
|
Changes in Rutherford grade at 7 days postoperatively or discharge day, 3 days postoperatively, and 6 months postoperatively |
7 days after surgery or discharge date, 30 days after surgery, 6 months surgery
|
|
Incidence rate of clinically driven target lesion revascularization (CD-TLR) at30 days and 6 months after surgery
Zeitfenster: 30 days after surgery, 6 months after surgery
|
Incidence rate of clinically driven target lesion revascularization (CD-TLR) at30 days and 6 months after surgery |
30 days after surgery, 6 months after surgery
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- LFBYIVL-202512
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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